Ben Salah 1995

Methods	Study design: randomised controlled trial Setting/location: Sidi‐ Bouzid. Tunisia Study period: 9 months Sample size calculation: the ideal sample size was estimated to be 120 based on a rate of success of treatment of 80%, 30%‐45% self‐healing in the vehicle group (type I error = 0.01and type II error = 0.10), and 10%‐20% loss to follow‐up
Participants	Type of Leishmania: L major Inclusion criteria: aged 2‐60 years, single lesion diagnosed by the presence of parasite in stained dermal smears, no previous anti‐leishmanial treatment Exclusion criteria: known allergy, adverse reactions to aminoglycoside antibiotics, multiple lesions, an active lesion measuring > 5 cm in diameter, if their ulcerated lesion had already persisted for more than 4 months, lesions < 3 cm from the eye, who by the physician's judgment required systemic antimonial treatment: participants with serious concomitant diseases, under medication for other illnesses likely to interfere with this study; pregnant women or nursing mothers. N randomised: 132. Paromomycin group: 66; vehicle: 66 Withdrawals: 17. Paromomycin group: 9; vehicle: 8 N assessed: 115. Paromomycin group: 57; vehicle: 58 Mean age (SD): paromomycin group: 19.2 years ( 2.31); vehicle: 18.2 years (1.65) Sex (ratio M:F): paromomycin group: 1.04; vehicle: 1.07 Baseline data: Location of the lesions: paromomycin group: upper limbs: 47.4%, lower limbs: 38.6% trunk: 5.3%, face: 8.8%. Vehicle: upper limbs: 41.4%, lower limbs: 51.7%, trunk: 3.5%, face: 3.5% Description of the lesions: paromomycin group: papular: 21.0%, nodular: 21.0%, nodo‐ulcerative: 73.7%, flat and ulcerative: 5.2%. Vehicle: papular: 19.0%, nodular: 17.2% nodo‐ulcerative: 74.1%, flat and ulcerative 7.0% Days from appearance of lesion to onset of treatment (mean (SD)): paromomycin group: 39.7 (2.95). Vehicle: 33.5 (2.75)
Interventions	Type of interventions: Group 1: 15% PR and 10% urea in soft white paraffin ointment Group 2: vehicle (10% urea in soft white paraffin) Duration of intervention: twice daily for 14 days Duration of follow‐up: 105 days
Outcomes	Healing rates: percentage of participants with complete re‐epithelisation of the lesion, 2.5 months after treatment initiation (105 days) Parasitological cure: percentage of lesions with negative smear and culture, 2.5 months after treatment initiation (105 days) Adverse effects Time points reported: days 15, 45, 105
Notes	Study funding sources: this investigation received funding from the United Nations Development Program/World Bank/World Health Organization Special Program for Research and TraininginTropical Diseases(grant ID:TDK910677) Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The tubes containing drug or placebo were supplied by the WHO/TDR, randomly numbered, and were given in numerical order to patients as they were admitted into the study."
Allocation concealment (selection bias)	Low risk	Quote: "The tubes containing drug or placebo were supplied by the WHO/TDR, randomly numbered, and were given in numerical order to patients as they were admitted into the study."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The code remained unknown to patients and investigators until the study had been completed"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The code remained unknown to patients and investigators until the study had been completed"
Incomplete outcome data (attrition bias) All outcomes	High risk	No defaults were included in the analysis
Selective reporting (reporting bias)	Low risk	Relevant outcomes were reported
Other bias	Low risk	Other items assessed correctly reported