Mostafavi 2013

Methods	Study design: randomised controlled trial Setting/location: skin and CL clinic in Gaz in Isfahan, Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: size of ulcer less than 5 cm in diameter, ≤ 5 lesions, duration of disease < 3 months Exclusion criteria: patients who had lesions on the face near the eyes or on the nose or ears, pregnancy, lactation, lupoid or sporotrichoid lesions, use of immunosuppressor drugs in the past 6 months and severe adverse effects, exacerbation of the disease N randomised: 40 participants (19 in prepared gel group and 21 vehicle gel mask) Withdrawals: 1 participant in prepared gel group N assessed: 39. 21 (100%) in vehicle gel group, and 18 in prepared gel group Mean age: 28.2 years Sex (male/female): 25/15 Baseline data: not described
Interventions	Type of interventions: Group 1: MA gel mask. Prepared by using polyvinyl alcohol (PVA), sodium carboxymethylcellulose, and hydroxypropyl methylcellulose as the base polymer and glycerin as the plasticizer, applied twice a day Group 2: vehicle gel mask, applied twice a day Duration of intervention: 6 weeks Co‐interventions: all of the participants received the standard treatment including ILMA weekly and cryotherapy every 2 weeks for a maximum of 6 weeks
Outcomes	Treatment outcome, defined as: Complete healing: complete disappearance of the lesion Moderate improvement: reduction in the size of the lesion more than 50% Mild improvements: reduction in the size of the lesion less than 50% No change: no considerable change in the size of the lesion Worsening: increase in the size of lesion Relapse: recurrence of lesion after complete healing Time points reported: 2 months after the end of treatment for relapse
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	Quote: "The patients were randomly divided into two groups" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open trial
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Open trials. Photography was done from all the lesions both at the first visit and all the follow‐up visits
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts
Selective reporting (reporting bias)	High risk	Protocol not available; not registered; in clinical trial registry; adverse effects not reported
Other bias	High risk	Sample size calculation, reporting of Leishmania spp involved and baseline comparability was not correctly reported