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. 2019 Mar 4;2019(3):CD011380. doi: 10.1002/14651858.CD011380.pub2

Wananukul 2012.

Methods Split‐body randomised comparative trial.
Duration: 2 weeks
Assessment at days 0, 3–4, 6–7, and 14
Unit of randomisation: left or right half of body
Unit of analysis: right/left side of body
Participants Inclusion criteria: clinical diagnosis of ISD, bilaterally symmetrical distribution of lesions, any severity, and various body sites
Exclusion criteria: any treatment within 2 weeks
Number of participants randomised: 75 (mild 51, moderate 22, severe 2)
Number of dropouts: 3, including 1 adverse event
Sex: 50 boys, 25 girls
Mean age: not reported; age range: 2–48 weeks
Location: Thailand, not stated if inpatient or outpatient setting (paediatric department of hospital)
Interventions Treatment (n = 75)
Hydrocortisone 1% lotion
Comparator (n = 75)
Licochalcone 0.025% lotion in ceramide and linoleic acid lipid base formulation (Eucerin soothing lotion 12%)
Applied twice daily for 14 days
No details regarding instructions given to participants' parents/carers
3/75 did not complete the study
Outcomes Primary outcome measure
  • Severity score: composite score (range: 0–9) of clinical presentation of erythema, scales, and crusts, each evaluated on a score of 0–3 (0 = no lesion, 1 = mild, 2 = moderate, 3 = severe). Categorised as mild (cumulative score 1–3), moderate (4–6), and severe (7–9).

  • Clearing rate at days 3–4, 6–7, and 14 and total number with complete clearance at end of study.


Evaluated at days 0, 3–4, 6–7, and 14.
Not stated who did the scoring.
Secondary outcome measures
  • Percentage of infants who develop adverse effects or intolerance to treatment


Assessed by parent or clinician report (or both).
No quality of life measures reported.
Notes We assessed the risk of bias due to the split‐body design. We assessed the risk of cross‐contamination from the products being applied using an overlapping method particularly on the scalp as high risk. We assessed the risk of systemic absorption of the product affecting the lesions on the contralateral side as moderate.
Funded by a research fund of the university.
No conflicts of interest declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "block randomisation".
Comment: did not fully describe method of randomisation.
Allocation concealment (selection bias) Low risk Quote: "sequentially numbered bottles from block randomisation before the study was started".
Comment: allocation likely concealed.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "repacked in bottles which were identical".
Comment: there was blinding of participants and personnel.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not explicitly stated who assessed the outcome
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3/75 did not complete the study.
Selective reporting (reporting bias) Unclear risk No study protocol.
Other bias High risk No apparent conflicts of interest or financial interests.
High risk due to split‐body design, risk of cross‐contamination of the products affecting the other half of the scalp, and a theoretical risk of systemic absorption potentially affecting the contralateral body side.

IGA: Investigator's Global Assessment; n: number of participants; SD: standard deviation.