Dogra 1991

Methods	Study design: randomised controlled trial Setting/location: India Study period: not described Sample size calculation: the number of subjects was determined by the standard method of Schork 1967
Participants	Type of Leishmania: L tropica in the area Inclusion criteria: demonstration of Leishmania from skin lesion by the slit smear technique. Exclusion criteria: pregnant women and children < 12 years old, suffering from any chronic illness, immunocompromised, allergic to sulphones, prior therapy for cutaneous Leishmania in any form, patients with scars of healed leishmanial lesions, lesions of > 4 months duration N randomised: 120. 60 in each group Withdrawals: 0 N assessed: 120 (100%), 60 in each group Age: range 15‐56 years Sex: 52 males/68 females Baseline data: the duration of the lesions ranged from 3 weeks to 3 months. Lesions were situated mainly on the exposed parts of the body (face, arms and feet). 46 participants (24 in dapsone group and 22 in placebo group) had a single lesion while 74 participants had multiple lesions (maximum 13).
Interventions	Type of interventions: Group 1: dapsone tablets (100 mg) Group 2: placebo tablets Duration of intervention: every 12 h for 6 weeks Duration of follow‐up: 6 weeks
Outcomes	Primary outcome: percentage of participants 'cured' at the end of treatment Secondary outcome: adverse effects Tertiary outcomes: microbiological or histopathological cure of skin lesions Time points reported: clinical response: days 15 and 45. Clinical and parasitological response: 6 weeks
Notes	Informed consent obtained: yes Study funding sources: — Possible conflicts of interest: —
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "... and was randomly allocated to receive either tablets of dapsone (100 mg) or placebo tablets which were identical in appearance" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Quote: "... and was randomly allocated to receive either tablets of dapsone (100 mg) or placebo tablets which were identical in appearance" Comment: no further information provided.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "double‐blind therapeutic trial" Comment: participants looks like blinded but no description about personnel blinding were provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "double‐blind therapeutic trial" Comment: no further information about blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	All relevant outcome data were provided
Selective reporting (reporting bias)	Low risk	Relevant outcomes were reported
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.