Lynen 1992

Methods	Study design: randomised controlled trial Setting/location: school children, Sudan Study period: 80 days Sample size calculation: not described
Participants	Type of Leishmania: Leishmania spp not specified but L major was presumed to be the causative parasite. Inclusion criteria: all positive smears Exclusion criteria: children who had received diminazene aceturate or previous treatment in hospital N randomised: 70. 35 in each group Withdrawals: 8. Berelin: 3; Savlon: 5. 2 children in Berelin group were not enrolled because they received diminazene aceturate before. 2 in Savlon group were excluded because they were treated for CL in the hospital N assessed: 62. Berelin: 32; Savlon: 30 Mean (SD) age: Berelin: 9.3 years (4.6); Savlon: 10.4 years (2.8) Sex (male/female): Berelin: 18/15; Savlon: 20/13 Baseline imbalances: comparability with regard to sex, age, number, size, duration and location of ulcer, and previous treatment taken Size of lesion (% (n/N)): small lesions (< 2 cm): Berelin: 58% (19/33); Savlon: 61% (20/33); big lesions (≥ 2 cm): Berelin: 42% (14/33); Savlon: 39% (13/33) Duration (% (n/N)): ≤ 2 months: Berelin: 52% (17/33); Savlon: 64% (21/33). >2 months: Berelin: 48% (16/33); Savlon: 36% (12/33)
Interventions	Type of interventions: Group 1: Berelin (1.05 g diminazene aceturate in 2.36 g of granulate, dissolved in 12.5 cc of distilled water) daily except on Fridays for 50 days Group 2: Savlon (cetrimide 15% + chlorhexidine 1.5% in a 2% solution) for 50 days Duration of treatment: 50 days Duration of follow‐up: one month
Outcomes	Primary outcome: percentage of participants 'cured' at the end of treatment. Cure was defined when the skin lesion was completely closed and covered with scar tissue, without the possibility to evoke secretions on pressure and if this apparent cure was sustained for at least 2 weeks Secondary outcomes: duration of remission and percentage of people with treated lesions that recur 20 to 35 days after cure Adverse effects Time points reported: at the end of treatment and at the end of follow‐up.
Notes	Study funding sources: not reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: insufficient detail was reported about the method used to generate the allocation sequence
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	A double‐blind study design was attempted, but could not be sustained as Savlon is a well‐known product and soapy on application
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low rates of dropouts (8/70, < 2.5%)
Selective reporting (reporting bias)	Low risk	The study protocol is not available but it is probably that the published reports include all expected outcomes
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported