Skip to main content
PMC home page
BMJ Clinical Evidence logoLink to BMJ Clinical Evidence
. 2010 Dec 7;2010:1713.

Seborrhoeic dermatitis

Luigi Naldi 1
PMCID: PMC3275327  PMID: 21418692

Abstract

Introduction

Seborrhoeic dermatitis affects at least 10% of the population. Malassezia (Pityrosporum) ovale is thought to be the causative organism, and causes 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 questions: What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults? What are the effects of topical treatments for seborrhoeic dermatitis of the face and body in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2010 (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 12 systematic reviews, RCTs, or observational 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, emollients, ketoconazole, lithium succinate, selenium sulphide, tar shampoo, terbinafine, and topical corticosteroids (betamethasone valerate, clobetasol propionate, clobetasone butyrate, hydrocortisone, mometasone furoate).

Key Points

Seborrhoeic dermatitis affects at least 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 yeasts 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, antifungal preparations containing ketoconazole improve symptoms compared with placebo.

  • Bifonazole and selenium sulphide 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.

In adults with seborrhoeic dermatitis of the face and body, antifungal preparations containing ketoconazole cream or gel and bifonazole cream may improve skin symptoms compared with placebo.

  • There is consensus that short courses of topical corticosteroids are effective, although we found no RCTs that assessed this.

  • We don't know whether terbinafine or selenium sulphide are also beneficial as we found no trials.

  • We don't know whether pimecrolimus, a topical calcineurin inhibitor, is beneficial, as we found few trials.

  • We don't know whether emollients or topical lithium succinate improve lesions compared with no treatment.

About this condition

Definition

Seborrhoeic dermatitis occurs in areas of the skin with a rich supply of sebaceous glands and manifests as red, sharply marginated lesions with greasy looking scales. On the face it mainly affects the medial aspect of the eyebrows, the area between the eyebrows, and the nasolabial folds. It may also affect the skin on the chest (commonly presternal) and the flexures. 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
Open in a new tab

Incidence/ Prevalence

Seborrhoeic dermatitis is estimated to affect about 10% of the general population.

Aetiology/ Risk factors

The cause of seborrhoeic dermatitis is unknown and the disease seems to be multifactorial. Malassezia yeasts, a genus classified in 7 species, are considered to have an important role in seborrhoeic dermatitis, producing 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 proinflammatory 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 species and reduce inflammation, although they tend to palliate rather than cure.

Outcomes

Symptom severity, including itching, scale, and erythema; adverse effects of treatment.

Methods

Clinical Evidence search and appraisal April 2010. The following databases were used to identify studies for this systematic review: Medline 1966 to April 2010, Embase 1980 to April 2010, and The Cochrane Database of Systematic Reviews 2010, April 2010 (online) (1966 to date of issue). When editing this review we used The Cochrane Database of Systematic Reviews 2010, Issue 2. An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing more than 20 individuals. Trials of less than 4 weeks' duration had to have at least 90% follow-up; trials lasting 4 weeks or longer had to have at least 80% follow-up. Trials of less than 1 week were excluded. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied 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 US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round 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.

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?
6 (787) Symptom severity Ketoconazole shampoo versus placebo 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results, methodological issues, and inclusion of children aged 12 to 16 years in a large RCT
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
1 (149) Symptom severity Selenium sulphide 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 –1 0 0 0 Moderate Quality point deducted for sparse data
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
What are the effects of topical treatments for seborrhoeic dermatitis of the face and body in adults?
3 (516) Symptom severity Ketoconazole versus placebo 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
1 (100) Symptom severity Bifonazole versus placebo 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (96) Symptom severity Topical calcineurin inhibitors versus placebo 4 –2 0 –1 0 Very low Quality points deducted for sparse data and differences at baseline. Directness point deducted for narrowness of population (generally older men)
Open in a new tab

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.

References

  • 1.National Center for Health Statistics. Skin conditions and related need for medical care among persons 1-74 years. United States, 1971-1974. (DHEW publication no. 79-1660). November 1978. http://www.cdc.gov/nchs/data/series/sr_11/sr11_212.pdf (accessed 19 November 2010). [Google Scholar]
  • 2.Coopman SA, Johnson RA, Platt R, et al. Cutaneous disease and drug reactions in HIV infection. N Engl J Med 1993;328:1670–1674. [DOI] [PubMed] [Google Scholar]
  • 3.Bettley FR, Marten RH. Unilateral seborrhoeic dermatitis following a nerve lesion. AMA Arch Dermatol 1956;73:110–115. [DOI] [PubMed] [Google Scholar]
  • 4.Wilson CL, Walshe M. Incidence of seborrhoeic dermatitis in spinal injury patients. Br J Dermatol 1988;119(suppl 33):48. [Google Scholar]
  • 5.Tager A. Seborrhoeic dermatitis in acute cardiac disease. Br J Dermatol 1964;76:367–369. [DOI] [PubMed] [Google Scholar]
  • 6.Barba A, Piubello W, Vantini I, et al. Skin lesions in chronic alcoholic pancreatitis. Dermatologica 1982;164:322–326. [DOI] [PubMed] [Google Scholar]
  • 7.Rook et al. Textbook of dermatology, 6th ed. Blackwell and Synergy: 639–643. [Google Scholar]
  • 8.Carr MM, Pryce DM, Ive FA. Treatment of seborrhoeic dermatitis with ketoconazole: I. response of seborrhoeic dermatitis of the scalp to topical ketoconazole. Br J Dermatol 1987;116:213–216. [DOI] [PubMed] [Google Scholar]
  • 9.Berger R, Mills OH. Double blind placebo-controlled trial of ketoconazole 2% shampoo in the treatment of moderate to severe dandruff. Adv Ther 1990;7:247–255. [Google Scholar]
  • 10.Danby FW, Maddin WS, Margesson LJ. A randomised, double-blind, placebo-controlled trial of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo in the treatment of moderate to severe dandruff. J Am Acad Dermatol 1993;29:1008–1012. [DOI] [PubMed] [Google Scholar]
  • 11.Davies DB, Boorman GC, Shuttleworth D. Comparative efficacy of shampoos containing coal tar (4.0% w/w; TarmedTM ), coal tar (4.0% w/w) plus ciclopirox olamine (1.0% w/w; TarmedTM AF) and ketoconazole (2.0% w/w; Nizoral® ) for the treatment of dandruff/seborrhoeic dermatitis. J Dermatol Treat 1999;10:177–183. [Google Scholar]
  • 12.Ratnavel RC, Squire RA, Boorman GC. Clinical efficacies of shampoos containing ciclopirox olamine (1.5%) and ketoconazole (2.0%) in the treatment of seborrhoeic dermatitis. J Dermatolog Treat 2007;18:88–96. [DOI] [PubMed] [Google Scholar]
  • 13.Reygagne P, Poncet M, Sidou F, et al. Clobetasol propionate shampoo 0.05% in the treatment of seborrheic dermatitis of the scalp: results of a pilot study. Cutis 2007;79:397–403. [PubMed] [Google Scholar]
  • 14.Elewski BE, Abramovits W, Kempers S, et al. A novel foam formulation of ketoconazole 2% for the treatment of seborrheic dermatitis on multiple body regions. J Drugs Dermatol 2007;6:1001–1008. [PubMed] [Google Scholar]
  • 15.Segal R, David A, Ingber R, et al. Treatment with bifonazole shampoo for seborrhoea and seborrhoeic dermatitis: a randomised, double blind study. Acta Derm Venereol (Stockh) 1992;72:454–455. [PubMed] [Google Scholar]
  • 16.Green CA, Farr PM, Shuster S. Treatment of seborrhoeic dermatitis with ketoconazole: II. response of seborrhoeic dermatitis of the face, scalp and trunk to topical ketoconazole. Br J Dermatol 1987;116:217–221. [DOI] [PubMed] [Google Scholar]
  • 17.Skinner RB, Noah PW, Taylor RM, et al. Double-blind treatment of seborrheic dermatitis cream with 2% ketoconazole cream. J Am Acad Dermatol 1985;12:852–856. [DOI] [PubMed] [Google Scholar]
  • 18.Elewski B, Ling MR, Phillips TJ. Efficacy and safety of a new once-daily topical ketoconazole 2% gel in the treatment of seborrheic dermatitis: a phase III trial. J Drugs Dermatol 2006;5:646–650. [PubMed] [Google Scholar]
  • 19.Zienicke H, Korting HC, Braun-Falco O, et al. Comparative efficacy and safety of bifonazole 1% cream and the corresponding base preparation in the treatment of seborrhoeic dermatitis. Mycoses 1993;36:325–331. [DOI] [PubMed] [Google Scholar]
  • 20.Cuelenaere C, De Bersaques J, Kint A. Use of topical lithium succinate in the treatment of seborrhoeic dermatitis. Dermatology 1992;184:194–197. [DOI] [PubMed] [Google Scholar]
  • 21.Warshaw EM, Wohlhuter RJ, Liu A, et al. Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis. J Am Acad Dermatol 2007;57:257–264. [DOI] [PubMed] [Google Scholar]
BMJ Clin Evid. 2010 Dec 7;2010:1713.

Ketoconazole scalp preparations

Summary

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

Benefits and harms

Ketoconazole shampoo versus placebo:

We found no systematic review. We found 6 RCTs.

Symptom severity

Ketoconazole shampoo compared with placebo Ketoconazole shampoo is 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 (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)
Significance not assessed

RCT		 53 people with moderate to severe dandruff, 28 (53%) of whom had seborrhoeic dermatitis Mean change in adherent dandruff score 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 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 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 Mean % change in participant-assessed scaling 4 weeks
–50.5% with ketoconazole shampoo 2%
–32.6% with placebo
Absolute numbers not reported
Significance not assessed

RCT
3-armed trial 		350 people with scalp seborrhoeic dermatitis 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
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 4 weeks
–20 with ketoconazole (2% shampoo)
+8 with placebo (shampoo base without ketoconazole)
Significance not assessed 		Effect size not calculated

RCT		 350 people with scalp dermatitis Mean % change in participant-assessed itching 4 weeks
–48.8% with ketoconazole shampoo 2%
–34.1% with placebo
Significance not assessed 		Effect size not calculated

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
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 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 		Effect size not calculated

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 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
Absolute numbers not reported
Significance not assessed 		Effect size not calculated

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
Open in a new tab

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
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 Eye stinging 29 days
5/146 (3%) with ketoconazole 2% shampoo
2/49 (4%) with placebo
Absolute numbers not reported
Significance not assessed
Open in a new tab

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 5-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 <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).

Substantive changes

Ketoconazole (scalp) One RCT added comparing ketoconazole 2% versus ciclopirox olamine 1.5% versus placebo. The RCT, which was primarily set up to assess the effectiveness of ciclopirox olamine, found that ketoconazole reduced scaling, itching, erythema, and global severity compared with placebo. Categorisation unchanged (Beneficial).

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Bifonazole scalp preparations

Summary

In adults with seborrhoeic dermatitis of the scalp, bifonazole is likely to be effective 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
Open in a new tab

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
Open in a new tab

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Selenium sulphide scalp preparations

Summary

In adults with seborrhoeic dermatitis of the scalp, selenium sulphide is likely to be effective at treating symptoms.

Benefits and harms

Selenium sulphide shampoo versus placebo:

We found no systematic review. We found one RCT.

Symptom severity

Selenium sulphide shampoo compared with placebo Selenium sulphide 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 29 days
66.7% with selenium sulphide 2.5% shampoo
44.5% with placebo (shampoo base without selenium sulphide)
Absolute numbers not reported
Reported as significant
P value not reported 		Effect size not calculated Selenium sulphide
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
54.7% with selenium sulphide 2.5% shampoo
28.6% with placebo (shampoo base without selenium sulphide)
Absolute numbers not reported
P = 0.004 		Effect size not calculated Selenium sulphide
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 		246 people with moderate to severe dandruff Adverse effects 29 days
with selenium sulphide 2.5% shampoo
with placebo (shampoo base without selenium sulphide)
Absolute results not reported
Open in a new tab

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Tar shampoo

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 is more effective than placebo at improving dandruff and redness at 29 days in people with seborrhoeic dermatitis or dandruff (moderate-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 4.0% 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 4.0% 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 from baseline 29 days
1.2 with coal tar 4.0% 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 4.0% 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 4.0% 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 = >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.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

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

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 0.05% used for 2.5 minutes

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 0.05% used for 5 minutes

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 0.05% used for 10 minutes
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 0.05% for 10 minutes
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 0.05% for 5 minutes

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
Open in a new tab

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 		Effect size not calculated
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 		Effect size not calculated
Open in a new tab

Further information on studies

None.

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.

Substantive changes

Topical corticosteroids One RCT added comparing clobetasol propionate 0.05% shampoo applied for 2.5, 5, and 10 minutes versus placebo. The RCT found that clobetasol propionate 0.05% applied twice weekly for 2.5, 5, or 10 minutes improved total severity score compared with placebo; that clobetasol propionate 0.05% applied twice weekly for 5 minutes improved erythema and itching compared with placebo; and that clobetasol propionate 0.05% applied twice weekly for 10 minutes improved scaling compared with placebo. However, the RCT found no significant differences between groups for other outcomes and times. Categorisation unchanged (Likely to be beneficial by consensus).

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Terbinafine scalp preparations

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).

Further information on studies

None.

Comment

Terbinafine versus placebo:

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. 2010 Dec 7;2010:1713.

Ketoconazole

Summary

Ketoconazole cream or gel may improve skin symptoms in adults with seborrhoeic dermatitis of the face and body.

Benefits and harms

Ketoconazole versus placebo:

We found no systematic review. We found two small RCTs comparing ketoconazole 2% cream versus placebo, and one large RCT comparing ketoconazole 2% gel versus placebo.

Symptom severity

Ketoconazole compared with placebo Ketoconazole seems more effective at increasing the number of people successfully treated, and at improving symptoms such as erythema, scaling, papules, and pruritus, at 4 weeks (moderate-quality evidence).

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

RCT		 20 people with seborrhoeic dermatitis of the face (80% also had seborrhoeic dermatitis of the scalp, 35% also had chest involvement, and 25% also had back involvement) Improvement in facial symptoms 4 weeks
9/10 (90%) with ketoconazole (2% cream)
0/10 (0%) with placebo
P value not reported

RCT		 37 people with seborrhoeic dermatitis Change in approximate mean sum of symptom scores from baseline 4 weeks
–19 with ketoconazole (2% cream)
–13 with placebo
P value not reported

RCT		 459 people with seborrhoeic dermatitis Proportion of people classed as successfully treated 4 weeks
58/229 (25%) with ketoconazole (2% gel)
32/230 (14%) with placebo (vehicle gel)
P = 0.0014 		Effect size not calculated Ketoconazole
Open in a new tab

Adverse effects

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

RCT		 20 people with seborrhoeic dermatitis of the face (80% also had seborrhoeic dermatitis of the scalp, 35% also had chest involvement, and 25% also had back involvement) Adverse effects 4 weeks
with ketoconazole (2% cream)
with placebo
Absolute results not reported

RCT		 37 people with seborrhoeic dermatitis Adverse effects 4 weeks
with ketoconazole (2% cream)
with placebo
Absolute results not reported

RCT		 459 people with seborrhoeic dermatitis Proportion of people with application site burning 4 weeks
2.6% with ketoconazole (2% gel)
2.6% with placebo (vehicle gel)
Absolute numbers not reported
Significance not assessed

RCT		 459 people with seborrhoeic dermatitis Proportion of people with treatment-related erythema 4 weeks
1.7% with ketoconazole (2% gel)
1.3% with placebo (vehicle gel)
Absolute numbers not reported
Significance not assessed

RCT		 459 people with seborrhoeic dermatitis Proportion of people with application site reaction 4 weeks
0.4% with ketoconazole (2% gel)
1.7% with placebo (vehicle gel)
Absolute numbers not reported
Significance not assessed
Open in a new tab

Further information on studies

Successful treatment was defined as both an erythema and scaling score of 0 (none) if the baseline score was 2 or less (moderate) or a score of 1 or less (mild) if the baseline score was 3 (severe) based on a 4-point scale for erythema and scaling, and an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), based on a 5-point scale measured at day 28.

Comment

See comment on ketoconazole for seborrheoic dermatitis of the scalp.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Bifonazole

Summary

Bifonazole cream may improve skin symptoms in adults with seborrhoeic dermatitis of the face and body.

Benefits and harms

Bifonazole versus placebo:

We found no systematic review. We found one RCT.

Symptom severity

Bifonazole cream compared with placebo Bifonazole cream may be more effective at improving symptoms and response to treatment at 4 weeks in people with seborrhoeic dermatitis of the face (low-quality evidence).

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

RCT		 100 people with seborrhoeic dermatitis of the face Proportion of people classed as healed 4 weeks
16/37 (43%) with bifonazole 1% cream
10/43 (23%) with placebo
Overall P value for healing, improvement, and treatment failure = 0.044
P values for individual outcomes not reported 		Effect size not calculated Bifonazole cream

RCT		 100 people with seborrhoeic dermatitis of the face Proportion of people classed as improved 4 weeks
20/37 (54%) with bifonazole 1% cream
26/43 (61%) with placebo
Overall P value for healing, improvement, and treatment failure = 0.044
P values for individual outcomes not reported 		Effect size not calculated Bifonazole cream

RCT		 100 people with seborrhoeic dermatitis of the face Rate of treatment failure 4 weeks
1/37 (3%) with bifonazole 1% cream
7/43 (16%) with placebo
Overall P value for healing, improvement, and treatment failure = 0.044
P values for individual outcomes not reported 		Effect size not calculated Bifonazole cream
Open in a new tab

Adverse effects

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

RCT		 100 people with seborrhoeic dermatitis of the face Proportion of people with a minor adverse effect 4 weeks
5/50 (10%) with bifonazole 1% cream
2/50 (4%) with placebo
P value not reported
Open in a new tab

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

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

Summary

In adults with seborrhoeic dermatitis of the face and body, short courses of topical corticosteroids are considered effective if used episodically, although we found no studies that assessed this.

We found no direct information from RCTs about whether topical corticosteroids (hydrocortisone, betamethasone valerate, clobetasone butyrate, mometasone furoate, or clobetasol propionate) 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 or RCTs comparing topical corticosteroids (hydrocortisone, betamethasone valerate, clobetasone butyrate, mometasone furoate, or clobetasol propionate) versus placebo in adults with seborrhoeic dermatitis of the face and body.

Further information on studies

None.

Comment

Although we found no RCTs of topical corticosteroids in adults with seborrhoeic dermatitis of the face or body, consensus regards their use as effective. It is current practice to use short courses of topical corticosteroids episodically in seborrhoeic dermatitis. Affected areas of the body are treated with short courses of potent topical corticosteroids (betamethasone valerate [0.1%], mometasone furoate [0.1%]) while the face is treated with short courses of moderate (clobetasone butyrate [0.05%]) or low potency (hydrocortisone [1%]) corticosteroids.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Emollients

Summary

We don't know whether emollients improve lesions compared with no treatment.

We found no direct information from RCTs about whether emollients are better than no active treatment in adults with seborrhoeic dermatitis of the face and body.

Benefits and harms

Emollients versus no treatment:

We found no systematic review or RCTs of sufficient quality comparing emollients versus no treatment in adults with seborrhoeic dermatitis of the face and body.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Lithium succinate

Summary

We don't know whether topical lithium succinate improves lesions compared with no treatment.

We found no direct information from RCTs about whether lithium succinate is better than no active treatment in adults with seborrhoeic dermatitis of the face and body.

Benefits and harms

Lithium succinate versus placebo:

We found no systematic review or RCTs of sufficient quality comparing lithium succinate versus placebo in adults with seborrhoeic dermatitis of the face and body (see comment).

Further information on studies

None.

Comment

We found one crossover RCT (30 people with seborrhoeic dermatitis of the face, trunk, or both), which compared lithium succinate 8% cream versus placebo. It found that lithium succinate significantly improved symptoms (graded on a 100-mm scale on severity of redness, scaling, greasiness, and overall clinical impression of the condition) compared with placebo (results not pre-crossover). However, these results should be interpreted with caution because of the potential for persistence of effects after crossover. The RCT also had a high withdrawal rate (37%) and it is not clear whether the analyses were conducted on an intention to treat basis. Withdrawals were owing to non-compliance (2 people with lithium succinate, 3 with placebo), local stinging sensation and erythema (1 person with lithium succinate, 2 with placebo), worsening of acne vulgaris (1 person with lithium succinate, 1 with placebo), or resolution of lesions (1 person, group not reported).

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Selenium sulphide

Summary

We don't know whether selenium sulphide is beneficial.

We found no direct information from RCTs about whether selenium sulphide is better than no active treatment in adults with seborrhoeic dermatitis of the face and body.

Benefits and harms

Selenium sulphide versus placebo:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Terbinafine

Summary

We don't know whether terbinafine is beneficial.

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

Benefits and harms

Terbinafine versus placebo:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2010 Dec 7;2010:1713.

Topical calcineurin inhibitors (pimecrolimus, tacrolimus)

Summary

We don't know whether topical calcineurin inhibitors are beneficial in the treatment of seborrhoeic dermatitis of the face.

Benefits and harms

Topical calcineurin inhibitors versus placebo:

We found no systematic review. We found one RCT comparing pimecrolimus cream 1% versus placebo for the treatment of facial seborrhoeic dermatitis.

Symptom severity

Pimecrolimus compared with placebo We don't know whether pimecrolimus cream 1% is more effective at improving symptoms (scaling and erythema) and response to treatment at 4 weeks in people with seborrhoeic dermatitis of the face (very low-quality evidence).

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

RCT		 96 people with seborrhoeic dermatitis of the face; 96% men, mean age 59 years Change from baseline in total target area score 4 weeks
3.7 with pimecrolimus cream 1%
3.3 with vehicle cream (placebo)
P = 0.191
The difference between groups favoured pimecrolimus on per protocol analysis: for full details see further information on studies 		Not significant
Scaling

RCT		 96 people with seborrhoeic dermatitis of the face; 96% men, mean age 59 years Change from baseline in scaling 4 weeks
1.9 with pimecrolimus cream 1%
1.7 with vehicle cream (placebo)
Significance not assessed
Erythema

RCT		 96 people with seborrhoeic dermatitis of the face; 96% men, mean age 59 years Change from baseline in erythema 4 weeks
1.8 with pimecrolimus cream 1%
1.6 with vehicle cream (placebo)
Significance not assessed
Open in a new tab

Adverse effects

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

RCT		 96 people with seborrhoeic dermatitis of the face; 96% men, mean age 59 years Proportion of people with at least one adverse effect 4 weeks
47% with pimecrolimus cream
33% with placebo
Absolute numbers not reported
Significance not assessed
Open in a new tab

Further information on studies

Erythema of the target area on the face was graded using a 4-point scale of: 0 = none; 1 = mild, faint red; 2 = moderate, dull red; or 3 = severe, bright red. Scaling of the target area of the face was scored using a 4-point scale of: 0 = none; 1 = mild, up to 10% of lesion; 2 = moderate, >10% to 50% of lesion; or 3 = severe, >50% of the lesion. The total target area score was the sum of the erythema and scaling target area scores (0–6 scale). Results from per protocol analysis The RCT found in a per protocol analysis that pimecrolimus cream 1% significantly improved total target area score compared with vehicle cream (change from baseline in total area score measured on a 6-point scale: 3.9 with pimecrolimus v 3.2 with vehicle; P = 0.0156). Per protocol analysis included 41 people in the pimecrolimus and 46 people in the placebo group. Differences in disease at baseline People in the vehicle group had milder disease at baseline in mean scale target score (2.12 with placebo v 2.32 with pimecrolimus; P = 0.0369) and mean facial Investigator's Global Assessment score (2.6 with placebo v 2.9 with pimecrolimus; P = 0.0471).

Comment

None.

Substantive changes

Topical calcineurin inhibitors (pimecrolimus, tacrolimus) One RCT added of pimecrolimus cream 1% for the treatment of facial seborrhoeic dermatitis, which found no significant difference between groups on intention-to-treat analysis, although pimecrolimus cream 1% improved total target area score compared with vehicle cream in a per protocol analysis (P = 0.0156). Categorisation unchanged (Unknown effectiveness).

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

RESOURCES