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. 2015 May 27;2015:1713.

Seborrhoeic dermatitis of the scalp

Luigi Naldi 1,#, Janouk Diphoorn 2,#
PMCID: PMC4445675  PMID: 26016669

Abstract

Introduction

Seborrhoeic dermatitis affects a variable proportion of the general population, ranging from 3% to 10%. Malassezia yeast species (previously referred to as Pityrosporum) are thought to be the responsible organisms, and cause inflammation by still poorly defined mechanisms. Seborrhoeic dermatitis tends to relapse after treatment.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2013 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 14 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: bifonazole, ciclopirox, ketoconazole, pyrithione zinc, selenium sulfide, tar shampoo, terbinafine, and topical corticosteroids (betamethasone valerate, clobetasol propionate, clobetasone butyrate, hydrocortisone, mometasone furoate).

Key Points

Seborrhoeic dermatitis affects at least 3% to 10% of the population and causes red patches with greasy scales on the face, chest, skin flexures, and scalp.

  • The cause of seborrhoeic dermatitis is unknown. Malassezia yeast species are thought to have an important role.

  • The inflammatory process may be mediated in susceptible people by fungal metabolites, namely free fatty acids, released from sebaceous triglycerides. The lipid layer of Malassezia can also modulate pro-inflammatory cytokine production by keratinocytes.

  • Known risk factors include immunodeficiency, neurological or cardiac disease, and alcoholic pancreatitis. In this review, however, we deal with treatment in immunocompetent adults who have no known predisposing conditions.

  • Seborrhoeic dermatitis tends to relapse after treatment.

In adults with seborrhoeic dermatitis of the scalp, topical antifungal preparations containing ketoconazole seem to improve symptoms compared with placebo and are also useful as treatment in the maintenance phase.

  • Ciclopirox seems to improve symptoms compared with placebo and may reduce relapse up to 12 weeks after initial treatment phase.

  • Bifonazole and selenium sulfide are also likely to be effective, but we don't know whether terbinafine is beneficial as we found no RCTs.

  • We found insufficient RCT evidence to fully assess the effectiveness of short courses of topical corticosteroids; however, there is consensus that topical corticosteroids are effective in treating seborrhoeic dermatitis of the scalp in adults. We found limited evidence that clobetasol propionate 0.05% may improve some symptoms of seborrhoeic dermatitis.

  • Tar shampoo may reduce scalp dandruff and redness compared with placebo; however, nowadays it is rarely used.

  • Pyrithione zinc may be more effective than vehicle shampoo at reducing dandruff severity; however, the evidence is too weak and limited to draw conclusions about the effectiveness.

Ketoconazole and ciclopirox have both been shown to be beneficial compared to placebo. In the next update of this review we will look for head-to-head comparisons of these.

Clinical context

General background

Seborrhoeic dermatitis is a chronic condition and one of the most common skin complaints. The scalp is one of the areas most frequently involved. Seborrhoeic dermatitis of the scalp can cause distress for patients in terms of itching and scaling, and also social embarrassment since the scalp is a visible area. The condition can have a major influence on a patient's life. Several treatment options are available.

Focus of the review

This review focuses on the topical treatment for seborrhoeic dermatitis of the scalp. It aims to discuss the suitable treatments in the acute phase as well as in the maintenance phase to try to prevent a relapse.

Comments on evidence

There is limited evidence available on the effectiveness of the different topical treatment agents for seborrhoeic dermatitis of the scalp. Only ketoconazole and ciclopirox have been studied in multiple RCTs. However, in several trials of ketoconazole, the focus is on dandruff rather than more specifically on seborrhoeic dermatitis. Moreover, long-term outcomes and prevention of relapse are scarcely studied and are areas for future research. This review deals with scalp treatment only. No RCTs are available on pimecrolimus or tacrolimus since no vehicle is available for the scalp.

Search and appraisal summary

The update literature search for this review was carried out from the date of the last search, April 2010 to November 2013. Searches for new options added to the scope at this update were carried out from 1966 to November 2013. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the review, please see the Methods section. Searching of electronic databases retrieved 75 studies. After deduplication and removal of conference abstracts, 59 records were screened for inclusion in the review. Appraisal of titles and abstracts led to the exclusion of 45 studies and the further review of 14 full publications. Of the 14 full articles evaluated, six RCTs were added at this update.

Additional information

In this version of the review we have only looked for effectiveness versus placebo to establish for which agents there is evidence of benefit. In the next update we will look for RCTs that compare the different active topical agents directly.

About this condition

Definition

Seborrhoeic dermatitis is one of the most common skin conditions. It occurs in areas of the skin with a rich supply of sebaceous glands and manifests as red, sharply marginated lesions with greasy-looking scales. The scalp is almost inevitably affected. Other areas commonly involved are the face and the chest; however, this review focuses on seborrhoeic dermatitis of the scalp. On the scalp it manifests as dry, flaking desquamation (dandruff) or yellow, greasy scaling with erythema. Dandruff is a lay term commonly used in the context of mild seborrhoeic dermatitis of the scalp. However, any scalp condition that produces scales could be labelled as dandruff. There is also an infantile variant, commonly affecting the scalp, flexures, and genital area, but this infantile variant seems to have a different pathogenesis from adult seborrhoeic dermatitis. Common differential diagnoses for seborrhoeic dermatitis of the scalp are psoriasis, eczema (see review on Atopic eczema), and tinea capitis (see table 1 ).

Table 1.

Differential diagnoses for seborrhoeic dermatitis of the scalp (see text).

Diagnosis Distinguishing features
Psoriasis Prominent erythema Tendency for hair line involvement More prominent silver scale Presence of psoriasis elsewhere (skin, nails, joints)
Eczema (atopic and contact dermatitis) Atopic dermatitis: • General skin examination • History Contact dermatitis: • Distribution of eczema • History
Tinea capitis Microscopy Fungal culture of scalp scrapings
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Incidence/ Prevalence

Seborrhoeic dermatitis is estimated to affect from 3% to 10% of the general population. The broad range in the prevalence depends on the age composition of the sample and the country analysed. The disease occurs more frequently in men than in women.

Aetiology/ Risk factors

The cause of seborrhoeic dermatitis is unknown and the disease seems to be multifactorial. Malassezia yeasts, a genus classified in 10 species, are considered to play an important role, especially M globosa and M restricta. They cause an inflammatory reaction that seems to be mediated by free fatty acids, released from sebaceous triglycerides by fungal enzymes such as lipases. The lipid layer of Malassezia can also modulate pro-inflammatory cytokine production by keratinocytes. Conditions that have been reported to predispose to seborrhoeic dermatitis include HIV, neurological conditions such as Parkinson's disease, neuronal damage such as facial nerve palsy, spinal injury, ischaemic heart disease, and alcoholic pancreatitis. In this review, we deal with treatment in immunocompetent adults who have no known predisposing conditions.

Prognosis

Seborrhoeic dermatitis is a chronic condition that tends to flare and remit spontaneously, and is prone to recurrence after treatment.

Aims of intervention

To reduce the symptoms and signs of seborrhoeic dermatitis with minimal adverse effects. Most therapeutic options aim to reduce colonisation with Malassezia yeast species and reduce inflammation, although they tend to palliate rather than cure.

Outcomes

Symptom severity, including itching, scaling, and erythema; adverse effects.

Methods

Clinical Evidence search and appraisal November 2013. The following databases were used to identify studies for this systematic review: Medline 1966 to November 2013, Embase 1980 to November 2013, and The Cochrane Database of Systematic Reviews 2013, issue 11 (1966 to date of issue). Additional searches were carried out in the Database of Abstracts of Reviews of Effects (DARE) and the Health Technology Assessment (HTA) database. We also searched for retractions of studies included in the review. Titles and abstracts identified by the initial search, run by an information specialist, were first assessed against predefined criteria by an evidence scanner. Full texts for potentially relevant studies were then assessed against predefined criteria by an evidence analyst. Studies selected for inclusion were discussed with an expert contributor. All data relevant to the review were then extracted by an evidence analyst. Study design criteria for inclusion in this review were published RCTs and systematic reviews of RCTs in the English language, at least double-blinded, and containing at least 20 individuals, of whom at least 90% were followed up in trials of less than 4 weeks and 80% were followed up in trials of over 4 weeks. There was a minimum length of follow-up from start of treatment of 1 week. We excluded all studies described as 'single-blinded', 'open', 'open label', or not blinded. We included RCTs and systematic reviews of RCTs where harms of an included intervention were assessed, applying the same study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table.

GRADE Evaluation of interventions for Seborrhoeic dermatitis of the scalp.

Important outcomes Symptom severity
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults?
7 (851) Symptom severity Ketoconazole shampoo versus placebo 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results and methodological issues
1 (51) Symptom severity Bifonazole shampoo versus placebo 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
5 (at least 1706) Symptom severity Ciclopirox/ciclopirox olamine versus placebo 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results and methodological issues
1 (53) Symptom severity Pyrithione zinc scalp preparations versus placebo 4 –2 0 –1 0 Very low Quality points deducted for sparse data and weak methods; directness point deducted for mixed population of dandruff and mild to moderate seborrhoeic dermatitis
1 (149) Symptom severity Selenium sulfide shampoo versus placebo 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (111) Symptom severity Tar shampoo versus placebo 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (55) Symptom severity Topical corticosteroids versus placebo 4 –3 –1 0 0 Very low Quality points deducted for sparse data, incomplete blinding, and unclear randomisation methods; consistency point deducted for different results at different time points
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We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

Glossary

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Very low-quality evidence

Any estimate of effect is very uncertain.

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Contributor Information

Luigi Naldi, Centro Studi GISED, Bergamo, Italy.

Janouk Diphoorn, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.

References

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BMJ Clin Evid. 2015 May 27;2015:1713.

Ketoconazole scalp preparations versus placebo

Summary

In adults with seborrhoeic dermatitis of the scalp, antifungal preparations containing ketoconazole seem to improve symptoms compared with placebo.

Benefits and harms

Ketoconazole shampoo versus placebo:

We found no systematic review. We found seven RCTs.

Symptom severity

Ketoconazole shampoo compared with placebo Ketoconazole shampoo seems more effective than placebo at improving scaling at up to 43 days and other scalp symptoms such as itching, redness, and dandruff at 4 weeks in people with seborrhoeic dermatitis of the scalp (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Scalp scaling

RCT
Crossover design 		20 people (16 male, 4 female) with either dandruff or seborrhoeic dermatitis (no distinction made between these; proportion with seborrhoeic dermatitis not reported) Approximate median change in participant-rated scaling score 4 weeks
–20 with ketoconazole (2% shampoo)
+15 with placebo (shampoo base without ketoconazole)
Absolute results reported graphically
Significance not assessed

RCT		 53 people with moderate to severe dandruff, 28 (53%) of whom had seborrhoeic dermatitis Mean change in adherent dandruff score (6 scalp areas assessed; 0 = no scaling to 10 = extremely severe scaling) 15 days
–12 with ketoconazole (2% shampoo)
–7 with placebo (shampoo base without ketoconazole)
P <0.05 		Effect size not calculated ketoconazole

RCT		 53 people with moderate to severe dandruff, 28 (53%) of whom had seborrhoeic dermatitis Mean change in adherent dandruff score (6 scalp areas assessed; 0 = no scaling to 10 = extremely severe scaling) 29 days
–19 with ketoconazole (2% shampoo)
–13 with placebo (shampoo base without ketoconazole)
P <0.05 		Effect size not calculated ketoconazole

RCT
3-armed trial 		246 people with moderate to severe dandruff % reduction in mean adherent dandruff score (6 scalp areas assessed; 0 = none and 9 to 10 = severe/heavy) from baseline 29 days
73.0% with ketoconazole (2% shampoo)
44.5% with placebo (shampoo base without ketoconazole)
Absolute numbers not reported
Significance not assessed

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Mean change in clinician-rated scaling score (0 = none to 4 = very severe) 29 days
–1.2 with ketoconazole (2% shampoo)
–0.3 with placebo (shampoo base without ketoconazole)
P <0.01 		Effect size not calculated ketoconazole

RCT
3-armed trial 		350 people with scalp seborrhoeic dermatitis (including people aged <16 years; see Further information on studies for details) Mean % change in participant-assessed scaling (scaling measured on a 100-mm VAS [0 = none to 100 = 'worst ever']) 4 weeks
–51% with ketoconazole shampoo 2%
–33% with placebo
Absolute numbers not reported
Significance not assessed

RCT
3-armed trial 		350 people with scalp seborrhoeic dermatitis (including people aged <16 years; see Further information on studies for details) Technician-assessed change in scaling (rated as cured or improved) 4 weeks
113/146 (77%) with ketoconazole shampoo 2%
35/49 (71%) with placebo
Significance not assessed

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Loose scaling 4 weeks
with ketoconazole foaming gel 2%
with vehicle shampoo (placebo)
Absolute results reported graphically
Reported as not significant 		Not significant

RCT
3-armed trial 		94 adults with seborrhoeic dermatitis (subgroup of larger cohort of 163 people with severe dandruff) Mean scores for scaling (assessed by technician using 5-point Likert scale (0 or 0.5 = none, 1 or 1.5 = slight, 2 or 2.5 = moderate, 3 or 3.5 = severe, 4 or 4.5 = very severe) 43 days
with ketoconazole 2% (32 people)
with vehicle (32 people)
Absolute results reported graphically
P <0.01 		Effect size not calculated ketoconazole
Scalp itching

RCT
Crossover design 		20 people (16 male, 4 female) with either dandruff or seborrhoeic dermatitis (no distinction made between these; proportion with seborrhoeic dermatitis not reported) Approximate median change in participant-rated itching score (measured on a 100-mm VAS [0 = none to 100 = 'worst ever']) 4 weeks
–20 with ketoconazole (2% shampoo)
+8 with placebo (shampoo base without ketoconazole)
Absolute results reported graphically
Significance not assessed

RCT		 350 people with scalp dermatitis (including people aged <16 years; see Further information on studies for more details) Mean % change in participant-assessed itching (measured on a 100-mm VAS [0 = none to 100 = 'worst ever']) 4 weeks
–49% with ketoconazole shampoo 2%
–34% with placebo
Significance not assessed

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Scalp itching 4 weeks
with ketoconazole foaming gel 2%
with vehicle shampoo (placebo)
Absolute results reported graphically
Reported as not significant 		Not significant

RCT
3-armed trial 		94 adults with seborrhoeic dermatitis (subgroup of larger cohort of 163 people with severe dandruff) Mean scores for itching (self-assessment using 8-point Likert scale [0 = completely cleared, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse]) 43 days
with ketoconazole 2% (32 people)
with vehicle (32 people)
Absolute results reported graphically
Reported as not significant
P values not reported 		Not significant
Scalp redness (erythema)

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Mean change in clinician-rated redness score (0 = none to 4 = very severe) 29 days
–1.3 with ketoconazole (2% shampoo)
–0.5 with placebo (shampoo base without ketoconazole)
P <0.001 		Effect size not calculated ketoconazole

RCT		 350 people with scalp dermatitis (including people aged <16 years; see Further information on studies for more details) Technician's overall assessment of clinical changes in erythema (rated as cured, much improved, or improved) 4 weeks
90/146 (62%) with ketoconazole
22/49 (45%) with placebo
Significance not assessed

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Erythema, on a scale from 0 to 3 4 weeks
0.1 with ketoconazole foaming gel 2%
0.7 with vehicle shampoo (placebo)
P = 0.027 		Effect size not calculated ketoconazole
Global severity

RCT		 53 people with moderate to severe dandruff, 28 (53%) of whom had seborrhoeic dermatitis Proportion of people responding to treatment (global evaluation of completely cleared, excellent, or good) 29 days
22/28 (79%) with ketoconazole (2% shampoo)
9/24 (38%) with placebo (shampoo base without ketoconazole)
P = 0.004 		Effect size not calculated ketoconazole

RCT
3-armed trial 		246 people with moderate to severe dandruff Proportion of people responding to treatment (global evaluation of completely cleared, excellent, or good) 29 days
65% with ketoconazole (2% shampoo)
29% with placebo (shampoo base without ketoconazole)
Absolute numbers not reported
P <0.001 		Effect size not calculated ketoconazole

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Area of scalp affected by seborrhoeic dermatitis 29 days
with ketoconazole (2% shampoo)
with placebo (shampoo base without ketoconazole)
Absolute results not reported
Reported as not significant
P value not reported 		Not significant

RCT
3-armed trial 		350 people with scalp seborrhoeic dermatitis (including people aged <16 years; see Further information on studies for more details) Mean change from baseline in area of scalp seborrhoeic dermatitis (cm2) 4 weeks
–41.4 cm2 with ketoconazole 2% shampoo
–20.0 cm2 with placebo
Significance not assessed

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Total symptom severity, on a scale from 0 to 3 4 weeks
0.7 with ketoconazole foaming gel 2%
2.6 with vehicle shampoo (placebo)
Absolute results reported graphically
P less than or equal to 0.02 		Effect size not calculated ketoconazole

RCT
3-armed trial 		94 adults with seborrhoeic dermatitis (subgroup of larger cohort of 163 people with severe dandruff) Global evaluation of clinical change from baseline (assessed by technician using 5-point Likert scale [0 or 0.5 = none, 1 or 1.5 = slight, 2 or 2.5 = moderate, 3 or 3.5 = severe, 4 or 4.5 = very severe]) 15 days
with ketoconazole 2% (32 people)
with vehicle (32 people)
Absolute results reported graphically
P <0.01 		Effect size not calculated ketoconazole
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
Crossover design 		20 people (16 male, 4 female) with either dandruff or seborrhoeic dermatitis (no distinction made between these; proportion with seborrhoeic dermatitis not reported) Adverse effects 4 weeks
with ketoconazole (2% shampoo)
with placebo (shampoo base without ketoconazole)
Absolute results not reported

RCT		 53 people with moderate to severe dandruff, 28 (53%) of whom had seborrhoeic dermatitis Adverse effects 29 days
with ketoconazole (2% shampoo)
with placebo (shampoo base without ketoconazole)
Absolute results not reported

RCT
3-armed trial 		246 people with moderate to severe dandruff Adverse effects 29 days
with ketoconazole (2% shampoo)
with placebo (shampoo base without ketoconazole)
Absolute numbers not reported

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Adverse effects 4 weeks
with ketoconazole foaming gel 2%
with vehicle shampoo (placebo)
Absolute results not reported

RCT
3-armed trial 		163 people with severe dandruff Adverse effects 43 days
with with ketoconazole 2%
with vehicle
Absolute results not reported
Scalp tenderness

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Scalp tenderness 29 days
with ketoconazole (2% shampoo)
with placebo (shampoo base without ketoconazole)
Absolute results not reported
Eye stinging

RCT
3-armed trial 		350 people with scalp seborrhoeic dermatitis (including people aged <16 years; see Further information on studies for more details) Eye stinging 29 days
5/146 (3%) with ketoconazole 2% shampoo
2/49 (4%) with placebo
Significance not assessed
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Further information on studies

The RCT included some children aged between 12 and 16 years old, which is outside our population of interest. However, as the mean age of participants was about 43 years, the proportion of children in the trial was unlikely to be high.

This five-arm RCT compared ketoconazole foaming gel 2%, clobetasol propionate shampoo 0.05% for 3 different durations, and a "clobetasol propionate vehicle" as the placebo treatment. The authors stated that, "Because of the different appearance of the shampoo and foaming gel preparations, blinding of the treatments' identity to the subjects was not possible. Blinding for investigators was maintained by using independent study personnel to dispense medication and collect returned medication". However, it is reasonable to assume that, in practice, participants were unaware of whether they were using an active treatment or the placebo.

Comment

We found one large RCT (1162 people aged at least 12 years, mean age about 45 years) that assessed the effects of ketoconazole cream 2% (210 people), ketoconazole foam 2% (427 people), vehicle cream (105 people), and vehicle foam (420 people) on seborrhoeic dermatitis of the scalp (62% of people in this RCT), face (33%), and body (5%).

The RCT did not carry out subgroup analyses for different body regions, and it included people aged under 16 years. We cannot, therefore, draw conclusions regarding our specific questions and population of interest, but have chosen to mention this RCT here as it is a large study that supports existing evidence that ketoconazole is beneficial in the treatment of seborrhoeic dermatitis of the scalp and body. The RCT found that ketoconazole foam significantly increased the proportion of people achieving treatment success (defined as Investigator's Static Global Assessment [ISGA] score of 0 or 1 [on a scale of 0–4] at week 4; people with a baseline score of 2 must have improved to a score of 0) compared with vehicle (placebo) foam (239/427 [56%] with ketoconazole foam v 176/420 [42%] with vehicle foam; P <0.0001), and that more people receiving ketoconazole cream achieved treatment success (56% with ketoconazole cream v 31% with vehicle cream; absolute numbers not reported; significance not assessed).

Clinical guide

In most of the RCTs there was a focus on dandruff instead of seborrhoeic dermatitis. Despite the fact that dandruff is a symptom of seborhoeic dermatitis, it might also include other diseases. Therefore, restrictions should be made to include only patients with seborrhoeic dermatitis in future research; that way a better evaluation of the precise effect of ketoconazole in seborrhoeic dermatitis can be achieved.

Ketoconazole 2% is the first-line treatment for seborrhoeic dermatitis of the scalp. In clinical trials it has been shown to be effective for the clearance as well as the maintenance phase. The advice is to use ketoconazole twice a week during 4 weeks for clearance, followed by once every week or every other week for maintenance to prevent a relapse. The RCTs we reviewed showed mainly the results of ketoconazole shampoo 2%; more research should be performed to compare the different types of applications of ketoconazole. One advantage of topical ketoconazole is that it has not been found to have any severe side effects; in very few cases scalp irritation was reported. Moreover, it is cheaper than some of the other treatment options.

Substantive changes

Ketoconazole scalp preparations versus placebo One RCT added. Categorisation unchanged (beneficial).

BMJ Clin Evid. 2015 May 27;2015:1713.

Bifonazole scalp preparations versus placebo

Summary

In adults with seborrhoeic dermatitis of the scalp, bifonazole may be more effective than placebo at treating symptoms.

Benefits and harms

Bifonazole shampoo versus placebo:

We found no systematic review. We found one RCT.

Symptom severity

Bifonazole shampoo compared with placebo Bifonazole shampoo may be more effective at improving symptoms such as scaling and pruritus, and overall symptom severity at 6 weeks, in people with seborrhoea or seborrhoeic dermatitis of the scalp (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Scalp scaling

RCT		 51 people with seborrhoea or seborrhoeic dermatitis of the scalp Improvement in severity of scaling (graded by a clinician on a 4-point scale from 0 = none to 3 = severe) 6 weeks
with bifonazole 1% shampoo
with placebo
Absolute results not reported
P = 0.01 		Effect size not calculated bifonazole
Pruritus

RCT		 51 people with seborrhoea or seborrhoeic dermatitis of the scalp Improvement in severity of pruritus (graded by a clinician on a 4-point scale from 0 = none to 3 = severe) 6 weeks
with bifonazole 1% shampoo
with placebo
Absolute results not reported
P = 0.008 		Effect size not calculated bifonazole
Global severity

RCT		 51 people with seborrhoea or seborrhoeic dermatitis of the scalp Improvement in overall severity (graded by a clinician on a 4-point scale from 0 = none to 3 = severe) 6 weeks
with bifonazole 1% shampoo
with placebo
Absolute results not reported
P = 0.012 		Effect size not calculated bifonazole
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT		 51 people with seborrhoea or seborrhoeic dermatitis of the scalp Adverse effects 6 weeks
with bifonazole 1% shampoo
with placebo
Absolute results not reported
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Comment

Bifonazole shampoo is available for the treatment of seborrhoeic dermatitis of the scalp in Europe and Canada. However, it is not available in the US and, therefore, cannot be considered as a treatment option there.

Clinical guide

There is limited RCT evidence that bifonazole may be effective in the treatment of seborrhoeic dermatitis of the scalp. At the moment there is a preference for ketoconazole in clinical practice because it is a well-known treatment for seborrhoeic dermatitis. In the UK, bifonazole is not a prescription treatment for seborrhoeic dermatitis. Bifonazole is also more expensive than ketoconazole.

Substantive changes

No new evidence

BMJ Clin Evid. 2015 May 27;2015:1713.

Ciclopirox/ciclopirox olamine scalp preparations versus placebo

Summary

In adults with seborrhoeic dermatitis of the scalp, antifungal preparations containing ciclpirox seem to improve symptoms compared with placebo.

There is some additional evidence that they may also reduce relapse up to 12 weeks after an initial treatment phase.

Benefits and harms

Ciclopirox/ciclopirox olamine versus placebo:

We found no systematic review. We found 5 RCTs.

Symptom severity

Ciclopirox/ciclopirox olamine versus placebo Ciclopirox seems more effective than placebo at improving scalp symptoms such as scaling, itching, redness, and dandruff at 4 weeks in people with seborrhoeic dermatitis of the scalp, and may also reduce relapse rate up to a further 12 weeks (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Total symptom severity

RCT		 178 adults with moderate, stable or exacerbating seborrhoeic dermatitis of the scalp Mean change from baseline in sum score (erythema, scaling, pruritus, and burning assessed on a 4-point Likert scale, 0–3 of none to severe) 4 weeks
with ciclopirox gel 0.77%
with vehicle
Absolute results reported graphically
P = 0.001 		Effect size not calculated ciclopirox

RCT
4-armed trial 		203 adults with stable or exacerbating seborrhoeic dermatitis of the scalp Mean change from baseline in sum score (itching, scaling, and inflammation assessed on a 6-point Likert scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = pronounced, 5 = severe) 4 weeks
–2.5 with ciclopirox 0.1%
–3.2 with ciclopirox 0.3%
–3.9 with ciclopirox 1.0%
–2.9 with vehicle
P = 0.6759 ciclopirox 0.1% v vehicle
P = 0.4206 ciclopirox 0.3% v vehicle
P = 0.0372 ciclopirox 1.0% v vehicle 		Effect size not calculated ciclopirox (1.0%)

RCT		 499 people with mild to pronounced stable or exacerbating seborrhoeic dermatitis of the scalp Mean change from baseline in sum score (scaling, itching and erythema) 4 weeks
–3.9 with ciclopirox 1%
–2.6 with vehicle
P <0.0001 		Effect size not calculated ciclopirox
Global severity

RCT		 178 adults with moderate, stable or exacerbating seborrhoeic dermatitis of the scalp Global evaluation scores (scale of 0–5: 0 = 100% clearance, 1 = 75–<100% clearance, 2 = 50–<75% clearance, 3 = <50% clearance, 4 = no change from baseline, 5 = flare of treatment area) up to 33 days
with ciclopirox gel 0.77%
with vehicle
Absolute results reported graphically
P = 0.01 		Effect size not calculated ciclopirox

RCT		 499 people with mild to pronounced stable or exacerbating seborrhoeic dermatitis of the scalp Effective treatment (score = 0 [or 1 if >3 at baseline] for status, scaling, erythema, and itching) at 4 weeks
65/250 (26%) with ciclopirox 1%
32/249 (13%) with vehicle
OR 2.38
95% CI 1.49 to 3.80
P = 0.0001 		Moderate effect size ciclopirox

RCT		 499 people with mild to pronounced stable or exacerbating seborrhoeic dermatitis of the scalp Global evaluation 'status' of seborrhoeic dermatitis score, mean change from baseline to 4 weeks (6-point scale: 0 = none to 5 = severe)
2.9 to 1.8 with ciclopirox 1%
2.9 to 2.3 with vehicle
Reported as not significant 		Not significant

RCT
3-armed trial 		942 adults with at least moderate stable or exacerbating seborrhoeic dermatitis of the scalp Proportion of patients effectively treated (efficacy parameters based on 6-point ordinal scales for status, scaling, and inflammation) 4 weeks
220/376 (58.5%) with ciclopirox 1% applied twice weekly
with vehicle (190 people)
OR 3.06
95% CI 2.11 to 4.42
P <0.001 		Moderate effect size ciclopirox

RCT
3-armed trial 		942 adults with at least moderate stable or exacerbating seborrhoeic dermatitis of the scalp Proportion of patients effectively treated (efficacy parameters based on 6-point ordinal scales for status, scaling, and inflammation) 4 weeks
171/376 (45.5%) with ciclopirox 1% applied once weekly
with vehicle (190 people)
OR 1.81
95% CI 1.25 to 2.61
P <0.001 ciclopirox 		Small effect size ciclopirox

RCT
3-armed trial 		428 adults with at least moderate stable or exacerbating seborrhoeic dermatitis of the scalp who previously responded positively to 4 weeks of ciclopirox 1% treatment (once or twice weekly) Relapse rate (defined as worsening of inflammation, scaling, itching by >2 points) 12 weeks
20/136 (14.7%) with ciclopirox 1% applied once weekly
32/145 (22.1%) with ciclopirox 1% applied twice weekly
50/141 (35.5%) with vehicle
P <0.001 both treatment groups combined (ciclopirox 1% once weekly and twice weekly) v vehicle 		Effect size not calculated ciclopirox

RCT
3-armed trial 		94 adults with seborrhoeic dermatitis (subgroup of larger cohort of 163 people with severe dandruff) Global evaluation, mean dandruff scores (reduction from baseline, assessed by technician) 43 days
with ciclopirox olamine 1.5% (30 people)
with vehicle (32 people)
Absolute results reported graphically
P <0.001 		Effect size not calculated ciclopirox
Scalp itching

RCT		 499 people with mild to pronounced stable or exacerbating seborrhoeic dermatitis of the scalp Itching, response rate (score = 0 [or 1 if >3 at baseline]) at 4 weeks
48% with ciclopirox 1%
30% with vehicle
Absolute numbers not reported
P <0.0001 		Effect size not calculated ciclopirox

RCT
3-armed trial 		94 adults with seborrhoeic dermatitis (subgroup of larger cohort of 163 people with severe dandruff) Mean scores for itching (self-assessment using 8-point Likert scale: 0 = completely cleared, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse) 43 days
with ciclopirox olamine 1.5% (30 people)
with vehicle (32 people)
Absolute results not reported
No statistically significant difference was reported between ciclopirox 1.5% v vehicle
P values not reported 		Not significant
Scalp redness (erythema)
499 people with mild to pronounced stable or exacerbating seborrhoeic dermatitis of the scalp Erythema, response rate (score = 0 [or 1 if >3 at baseline]) at 4 weeks
39% with ciclopirox 1%
21% with vehicle
Absolute numbers not reported
P <0.0001 		Effect size not calculated ciclopirox
Scalp scaling

RCT		 499 people with mild to pronounced stable or exacerbating seborrhoeic dermatitis of the scalp Scaling, response rate (score = 0 [or 1 if >3 at baseline]) at 4 weeks
34% with ciclopirox 1%
20% with vehicle
Absolute numbers not reported
P = 0.0002 		Effect size not calculated ciclopirox
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT		 499 people with stable or exacerbating seborrhoeic dermatitis of the scalp Serious adverse events 4 weeks
2/250 (0.8%) with ciclopirox 1%
0/249 (0%) with vehicle
Not reported

RCT		 499 people with stable or exacerbating seborrhoeic dermatitis of the scalp Withdrawal due to adverse events
2/250 (0.8%) with ciclopirox 1%
3/249 (1%) with vehicle

RCT
3-armed trial 		942 adults with at least moderate stable or exacerbating seborrhoeic dermatitis of the scalp Serious adverse events
with ciclopirox 1% applied once weekly
with ciclopirox 1% applied twice weekly
with vehicle

RCT
3-armed trial 		163 people with severe dandruff Adverse effects 43 days
with ciclopirox
with vehicle
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Further information on studies

The prophylaxis part of the study commenced immediately after the 4-week treatment section was completed, to assess the prophylactic efficacy of different application frequencies of ciclopirox shampoo. A total of 428 responders were again randomised (maintaining blinding) to three equal groups to use ciclopirox once every week, once every 2 weeks, or vehicle. The study was sponsored and conducted by Aventis Pharma.

Comment

The results of the available RCTs suggest that ciclopirox is effective in the treatment of seborrhoeic dermatitis of the scalp. In a single trial, ciclopirox also reduced the relapse rate in the subsequent 12 weeks after clearance when used once every week or other week. However, more research should be done to define the optimal treatment dosage of ciclopirox and to investigate the prevention of relapse. In this version of the review we have only looked for effectiveness versus placebo. In the next update of this review we will look for head-to-head comparisons, in particular ciclopirox versus ketoconazole, to determine the differences in treatment effect and adverse effects. While we did not search for head-to-head comparisons, we have included one three-armed RCT (163 people with severe dandruff, with a subgroup of 94 people with seborrhoeic dermatitis) comparing ciclopirox, ketoconazole, and placebo (results versus placebo reported above and in option on Ketoconazole). It found no significant difference in mean dandruff scores between ciclopirox and ketoconazole on days 8, 15, or 29 (n = 108, P value not reported). However, at day 43, the mean change from baseline was significantly more with ketoconazole (41.3 to 7.2) compared with cicloprirox (40.7 to 14.6), P <0.01. For seborrhoeic dermatitis (n = 62, measured by technician assessment of scaling, redness, and area affected) there was no significant difference between ciclopirox and ketoconazole at any time point.

Clinical guide

In clinical practice, ciclopirox could be used for the treatment of seborrhoeic dermatitis of the scalp as an alternative to ketoconazole. The results of RCTs suggest that ciclopirox 1% twice a week would be a good alternative to ketoconazole for clearance and maintenance. It is not associated with severe adverse effects, aside from local irritation of the skin. The local costs of ciclopirox in comparison with ketoconazole should be considered when deciding about treatment. In the UK, ciclopirox shampoo is not presently a prescription treatment for seborrhoeic dermatitis.

Substantive changes

Ciclopirox/ciclopirox olamine scalp preparations versus placebo New option. Five RCTs added. Categorised as 'beneficial'.

BMJ Clin Evid. 2015 May 27;2015:1713.

Pyrithione zinc scalp preparations versus placebo

Summary

Pyrithione zinc may be more effective than vehicle shampoo at reducing mean dandruff severity at 1 week.

However, the evidence is weak and limited to one small RCT in a mixed population of people with dandruff or mild to moderate seborrhoeic dermatitis.

Benefits and harms

Pyrithione zinc scalp preparations versus placebo:

We found one RCT comparing pyrithione zinc 0.5% and 1.0% with a vehicle shampoo for 4 weeks in people with dandruff or mild to moderate seborrhoeic dermatitis.

Symptom severity

Pyrithione zinc scalp preparations versus placebo Zinc pyrithione may be more effective than vehicle shampoo at reducing mean dandruff severity at 1 week in people with mild to moderate seborrhoeic dermatitis of the scalp; however, we don't know how effective it is over longer treatment periods, and evidence is limited to one small study (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Total symptom severity

RCT
3-armed trial 		53 people with dandruff or mild to moderate seborrhoeic dermatitis of the scalp Mean dandruff severity (assessed using adherent scalp scaling score) 1 week
43.3 with zinc pyrithione 0.5% (18 people)
44.6 with zinc pyrithione 1.0% (20 people)
54.9 with vehicle (15 people)
P <0.05 zinc pyrithione 0.5% or 1.0% v vehicle 		Effect size not calculated zinc pyrithione
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

The study included people with dandruff or mild to moderate seborrhoeic dermatitis. It was unclear how many of the 53 people randomised had a diagnosis of seborrhoeic dermatitis. People with severe seborrhoeic dermatitis were excluded. All participants completed a pre-randomisation phase where they were given a vehicle shampoo for 5 to 7 weeks. Only those with a Harding Scale Dandruff Severity Score greater than 28 at the end of this phase were randomised. The method of randomisation and allocation concealment were unclear. People were treated for 4 weeks and then all were given the vehicle shampoo for 6 weeks (regression phase). The study reported that the anti-dandruff efficacy of a zinc pyrithione-containing shampoo is highly dependent on the level of the active ingredient delivered to the scalp during the washing process.

Comment

There is very limited evidence available on pyrithione zinc. The results of the only available trial suggest that pyrithione zinc is effective in the treatment of seborrhoeic dermatitis by reducing dandruff. The long-term efficacy and possible adverse effects were not evaluated.

Clinical guide

Because there is only limited evidence for the use of pyrithione zinc in people with seborrhoeic dermatitis of the scalp, it should not be considered as a first-line treatment.

Substantive changes

Pyrithione zinc scalp preparations versus placebo New option. One RCT added. Categorised as 'unknown effectiveness'.

BMJ Clin Evid. 2015 May 27;2015:1713.

Selenium sulfide scalp preparations versus placebo

Summary

In adults with seborrhoeic dermatitis of the scalp, selenium sulfide may be more effective than placebo at treating symptoms.

Benefits and harms

Selenium sulfide shampoo versus placebo:

We found no systematic review. We found one RCT.

Symptom severity

Selenium sulfide shampoo compared with placebo Selenium sulfide shampoo may be more effective at reducing dandruff, and at increasing response to treatment at 29 days, in people with moderate to severe dandruff (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Scalp scaling

RCT
3-armed trial 		246 people with moderate to severe dandruff % reduction in mean adherent dandruff score from baseline (6 scalp areas were assessed; dandruff score ranged from 0 = none to 9–10 = severe/heavy) 29 days
67% with selenium sulfide 2.5% shampoo
45% with placebo (shampoo base without selenium sulfide)
Absolute numbers not reported
Reported as significant
P value not reported 		Effect size not calculated selenium sulfide
Global severity

RCT
3-armed trial 		246 people with moderate to severe dandruff Proportion of people responding to treatment (global evaluation of completely cleared, excellent, or good) 29 days
55% with selenium sulfide 2.5% shampoo
29% with placebo (shampoo base without selenium sulfide)
Absolute numbers not reported
P = 0.004 		Effect size not calculated selenium sulfide
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
3-armed trial 		246 people with moderate to severe dandruff Adverse effects 29 days
with selenium sulfide 2.5% shampoo
with placebo (shampoo base without selenium sulfide)
Absolute results not reported
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Comment

None.

Clinical guide

Selenium sulfide seems to be effective in the treatment of seborrhoeic dermatitis of the scalp. However, there is limited evidence available. Selenium sulfide is associated with more side effects than ketoconazole. These are not frequent, but when they occur, burning sensations of the scalp and itching are most often reported. Therefore, selenium sulfide could not be considered as the first-choice treatment, but might be useful as an alternative when other treatments are not effective.

Substantive changes

No new evidence

BMJ Clin Evid. 2015 May 27;2015:1713.

Tar shampoo versus placebo

Summary

In adults with seborrhoeic dermatitis of the scalp, tar shampoo may reduce scalp dandruff and redness compared with placebo.

Benefits and harms

Tar shampoo versus placebo:

We found no systematic review. We found one RCT.

Symptom severity

Tar shampoo compared with placebo Tar shampoo may be more effective than placebo at improving dandruff and redness at 29 days in people with seborrhoeic dermatitis or dandruff (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Scalp scaling

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Mean change in dandruff score from baseline (assessed by a technician) 29 days
–31 with coal tar 4% plus ciclopirox olamine 1% shampoo
–19 with placebo (shampoo base without ketoconazole)
P <0.01 		Effect size not calculated tar shampoo

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Scaling or area of seborrhoeic dermatitis 29 days
with coal tar 4% plus ciclopirox olamine 1% shampoo
with placebo (shampoo base without ketoconazole)
Absolute results not reported
Reported as not significant 		Not significant
Scalp redness (erythema)

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Mean change in redness score (graded by a clinician on a 5-point scale from 0 = none to 4 = very severe) from baseline 29 days
1.2 with coal tar 4% plus ciclopirox olamine 1% shampoo
0.6 with placebo (shampoo base without ketoconazole)
P <0.05 		Effect size not calculated tar shampoo
Global severity

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Area of scalp affected by seborrhoeic dermatitis 29 days
with coal tar 4% plus ciclopirox olamine 1% shampoo
with placebo (shampoo base without ketoconazole)
Absolute results not reported
Reported as not significant
P value not reported 		Not significant
Open in a new tab

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
3-armed trial 		163 people with seborrhoeic dermatitis or dandruff Adverse effects 29 days
with coal tar 4% plus ciclopirox olamine 1% shampoo
with placebo (shampoo base without ketoconazole)
Absolute results not reported
Open in a new tab

Further information on studies

Dandruff score calculated by multiplying size of affected area by severity; size of affected area scored from 0 = 10% to 4 =  more than 70%; severity scored from 1 = small flakes resembling a white powder to 5 = flakes adhering to the scalp as white or yellow plates.

Comment

None.

Clinical guide

Tar shampoos are likely to be effective in seborrhoeic dermatitis of the scalp. However, they are not often used for this indication any more. Their distinct smell is unpleasant and may lead to a lack of compliance. Also, tar shampoo is associated with local skin irritation and a possible carcinogenic effect in long-term use.

Substantive changes

Tar shampoo versus placebo Existing evidence re-evaluated. Categorisation unchanged (likely to be beneficial).

BMJ Clin Evid. 2015 May 27;2015:1713.

Terbinafine scalp preparations versus placebo

Summary

We don't know whether terbinafine is beneficial in adults with seborrhoeic dermatitis of the scalp as no studies have been found.

We found no direct information from RCTs about whether terbinafine is better than no active treatment in adults with seborrhoeic dermatitis of the scalp.

Benefits and harms

Terbinafine versus placebo:

We found no systematic review or RCTs (see comment below).

Comment

Terbinafine is not manufactured as a scalp preparation in the UK and is not known to be available worldwide.

Substantive changes

No new evidence

BMJ Clin Evid. 2015 May 27;2015:1713.

Topical corticosteroids (hydrocortisone, betamethasone valerate, clobetasone butyrate, mometasone furoate, clobetasol propionate) versus placebo

Summary

There is consensus that topical corticosteroids are effective in treating seborrhoeic dermatitis of the scalp in adults.

We found limited evidence that clobetasol propionate 0.05% may improve some symptoms of scalp seborrhoeic dermatitis.

We found no direct information from RCTs about whether topical corticosteroids other than clobetasol propionate shampoo 0.05% are better than no active treatment for seborrhoeic dermatitis of the scalp in adults.

Benefits and harms

Topical corticosteroids versus placebo:

We found no systematic review. We found one RCT.

Symptom severity

Clobetasol propionate shampoo 0.05% compared with placebo Clobetasol propionate shampoo 0.05% applied twice weekly for 2.5, 5, or 10 minutes may be more effective at 4 weeks in improving total symptom severity scores. Clobetasol propionate shampoo 0.05% applied twice weekly for 5 minutes may be more effective at improving erythema and itching. Clobetasol propionate shampoo 0.05% applied twice weekly for 10 minutes may be more effective at improving scaling. We don't know whether clobetasol propionate used for other durations is more effective at improving symptoms (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Total symptom severity

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Total symptom severity on a scale of 0 to 3 (0 = no symptoms, 3 = most severe) 4 weeks
0.8 with clobetasol propionate shampoo 0.05% used for 2.5 minutes
2.6 with vehicle shampoo (placebo)
P less than or equal to 0.02 		Effect size not calculated clobetasol propionate

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Total symptom severity, on a scale of 0 to 3 (0 = no symptoms, 3 = most severe) 4 weeks
0.6 with clobetasol propionate shampoo 0.05% used for 5 minutes
2.6 with vehicle shampoo (placebo)
P less than or equal to 0.02 		Effect size not calculated clobetasol propionate

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Total symptom severity, on a scale of 0 to 3 (0 = no symptoms, 3 = most severe) 4 weeks
0.7 with clobetasol propionate shampoo 0.05% used for 10 minutes
2.6 with vehicle shampoo (placebo)
P less than or equal to 0.02 		Effect size not calculated clobetasol propionate
Scalp scaling

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Loose scaling, on a scale from 0 to 3 (0 = clear, 3 = worst) 4 weeks
with clobetasol propionate shampoo 0.05% for 2.5 minutes
with vehicle shampoo (placebo)
Absolute results not reported
Reported as not significant 		Not significant

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Loose scaling, on a scale from 0 to 3 (0 = clear, 3 = worst) 4 weeks
0.4 with clobetasol propionate shampoo 0.05% for 5 minutes
1.0 with vehicle shampoo (placebo)
P = 0.051 		Not significant

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Loose scaling, on a scale from 0 to 3 (0 = clear, 3 = worst) 4 weeks
0.3 with clobetasol propionate shampoo 0.05% for 10 minutes
1.0 with vehicle shampoo (placebo)
P = 0.027 		Effect size not calculated clobetasol propionate
Scalp redness (erythema)

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Erythema, on a scale of 0 to 3 (0 = clear, 3 = worst) 4 weeks
with clobetasol propionate shampoo 0.05% for 2.5 minutes
with vehicle shampoo (placebo)
Absolute numbers not reported
Reported as not significant 		Not significant

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Erythema, on a scale of 0 to 3 (0 = clear, 3 = worst) 4 weeks
0.1 with clobetasol propionate shampoo 0.05% for 5 minutes
0.7 with vehicle shampoo (placebo)
P = 0.024 		Effect size not calculated clobetasol propionate

RCT
Crossover design
5-armed trial 		55 people with scalp seborrhoeic dermatitis Erythema, on a scale of 0 to 3 (0 = clear, 3 = worst) 4 weeks
with clobetasol propionate shampoo 0.05% for 10 minutes
with vehicle shampoo (placebo)
Absolute results not reported
Reported as not significant 		Not significant
Scalp itching

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Itching, measured on a 100-mm analogue scale (0 = no itching, 100 = worst) 4 weeks
with clobetasol propionate shampoo 0.05% for 2.5 minutes
with vehicle shampoo (placebo)
Absolute results not reported
Reported as not significant 		Not significant

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Itching, measured on a 100-mm analogue scale (0 = no itching, 100 = worst) 4 weeks
4.8 mm with clobetasol propionate shampoo 0.05% for 5 minutes
34.0 mm with vehicle shampoo (placebo)
P = 0.007

RCT
5-armed trial 		55 people with scalp seborrhoeic dermatitis Itching, measured on a 100-mm analogue scale (0 = no itching, 100 = worst) 4 weeks
with clobetasol propionate shampoo 0.05% for 10 minutes
with vehicle shampoo (placebo)
Absolute results not reported
Reported as not significant 		Not significant
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Folliculitis

RCT
5-armed trial 		55 people with seborrhoeic dermatitis of the scalp Folliculitis 4 weeks
1/11 with clobetasol propionate 0.05% shampoo for 5 minutes
0/11 with clobetasol propionate vehicle (placebo)
Significance not assessed
Dry skin

RCT
5-armed trial 		55 people with seborrhoeic dermatitis of the scalp Dry skin 4 weeks
1/11 with clobetasol propionate 0.05% shampoo for 10 minutes
0/11 with vehicle shampoo (placebo)
Significance not assessed
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Comment

Although limited evidence is available from a single small RCT concerning clobetasol propionate shampoo 0.05%, there is consensus that topical corticosteroids are effective in treating seborrhoeic dermatitis of the scalp in adults.

Clinical guide

In clinical practice, topical corticosteroids are considered as a suitable treatment option in the clearance phase to reduce the acute state of seborrhoeic dermatitis of the scalp. However, they are not recommended as maintenance therapy because of their known adverse effects such as skin atrophy, striae, hypertrichosis, and folliculitis with long-term use.

Substantive changes

No new evidence

Articles from BMJ Clinical Evidence are provided here courtesy of BMJ Publishing Group

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