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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
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