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 |
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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) |
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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 |
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Outcomes |
Primary outcome measure
Evaluated at days 0, 3–4, 6–7, and 14. Not stated who did the scoring. Secondary outcome measures
Assessed by parent or clinician report (or both). No quality of life measures reported. |
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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. |
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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.