Larbi 1995

Methods	Study design: randomised controlled trial Setting/location: Saudi Arabia Study period: not described Sample size calculation: not described
Participants	Type of Leishmania:L major Inclusion criteria: only participants in whom parasites (amastigotes) were demonstrated were enrolled Exclusion criteria: pregnancy, chronic illness, immunocompromised or hyper allergic reaction to the trial drugs, treatment with regular medications such as antituberculous agents and steroids, which might have affected specific therapy, treatment with anti‐leishmanial drugs within the previous months, the presence of scars of previously treated lesions N randomised: 58. 2% miconazole cream: 27; 1% clotrimazole cream: 31 Withdrawals: 4: 2% miconazole cream: 4 (lost to follow‐up); 1% clotrimazole cream: 0 N participants assessed (lesions): 54 (151). 2% miconazole cream:n23 (62); 1% clotrimazole cream: 31 (89) Mean (SD) age: 2% miconazole cream: 19.5 years (15.4); 1% clotrimazole cream: 21.5 years (12.8) Sex (male/female): 42/12. 2% miconazole cream: 17/6; 1% clotrimazole cream: 25/6 Baseline data: Lesion type (%): 2% miconazole group: nodular: 21 (34%), nodule‐ulcerative: 37 (59%) and papular: 4 (7%). 1% clotrimazole group: nodular: 36 (41%), nodule‐ulcerative: 50 (56%) and papular: 4 (3%) Location of lesions: 2% miconazole group(percentage): the lower limbs: 56%; upper limbs 39%; head, neck, upper chest: 5%. 1% clotrimazole group: lower limbs: 34%; upper limbs: 46%; head, neck, upper chest: 19%, abdomen and groin: 1%. 2% miconazole group: MNL: Saudi: 2.2 and non‐Saudi 3.4. MSL (range): 1.02 cm (0.06‐5). Mean duration of lesions before treatment (SD): 2.1 weeks (1.3) 1% clotrimazole group: MNL: Saudi: 2.3 and non‐Saudi 3.5. MSL (range): 1.38 cm (0.05‐6). Mean duration of lesions before treatment (SD): 2.3 weeks (1.2)
Interventions	Type of interventions: Group 1: 2% miconazole cream Group 2: 1% clotrimazole cream Duration of intervention: twice daily for 30 consecutive days Duration of follow‐up: 30 days
Outcomes	Healing rates: percentage of lesions 'cured' at the end of treatment. Response to treatment was based on results of repeated parasitologic evaluation and/or clinical changes using the same parameters as in the follow‐up. On this basis, response to treatment was graded into 4 categories: Lesion fully healed (lesions were completely healed and parasitologically negative Size reduced (lesions showed a reduction in infiltration, erythema, and size with positive or negative parasitology No change (lesions did not show any change in infiltration, erythema, size, and parasitology Lesions worsened or size increased (there was an increase in the size of the lesion and a worsening of infiltration and erythema and positive parasitology) Adverse effects Time points reported: at the end of treatment
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)	Low risk	Quote: "Randomization was carried out by using a table of random numbers"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Patients admitted into the trial were given unlabeled tubes containing either 1% clotrimazole cream or 2% miconazole" Comment: we think that the outcome is unlikely to be influenced
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Of 27 participants treated with 2% miconazole, 4 defaulted and were lost to follow‐up; they were excluded from analysis" (4/27 = 14.28%)
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but he published reports probably include all expected outcomes.
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.