Methods | Clinical randomised trial conducted from March 2008 through 2009 in the dermatology department of Quaem University Hospital, Mashhad, Iran Sample size calculation: not described |
Participants |
Leishamania type: not described Inclusion criteria: positive smear for leishmaniasis with disease duration of less than 12 weeks, no treatment for the current condition before and volunteer to participate in the study Exclusion criteria: pregnancy, breastfeeding, history of simultaneous treatment with other methods before or during the trial, history of local cutaneous or systemic diseases in the past 2 months, history of intolerance or allergy to macrolides, severe underlying diseases such as cardiovascular, renal, or hepatic diseases N randomised: 96; 26 (43 lesions) azithromycin, 40 (54 lesions) MA (Glucantime) Withdrawals: 2 azithromycin group N assessed: 94; 24 (40 lesions) azithromycin, 40 (54 lesions) MA |
Interventions |
Group 1: topical liposomal form of azithromycin was administered for the first group twice daily. Group 2: the other group was treated by weekly ILMA with a volume of 0.5–2 cm³ into each lesion till complete blanching of the lesion occurred Clinical evaluations were performed every week during the treatment course (8 weeks) by a single dermatologist in both groups. The participants were followed up for recurrence or complications 6 and 12 months after the end of the treatment course. |
Outcomes |
Complete cure was defined as full re‐epithelialisation, disappearance of oedema, induration, and other signs of inflammation, and a negative direct skin smear result Improvement rate (%): complete improvement (full re‐epithelialisation of the lesions for ulcerative ones or disappearance of induration and erythema; significant improvement (decrease in induration size > 60%); moderate improvement (decrease in induration size between 30% and 60%; slight improvement (decrease in induration size of < 30%). Adverse effects |
Notes |
Study funding sources: none declared Possible conflicts of interest: none declared |