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IRCT138707201166N2 IRCT 2008-10-21 Tehran University of Medical Sciences Assessment of the efficacy of dressings in the treatment of cutaneous leishmaniasis due to Leishmania major: A randomized, single-blind controlled clinical trial Assessment of the efficacy of the combination of a silver-containing dressing with intralesional meglumine antimoniate injections in comparison with a combination of an inert dressing and intralesional meglumine antimoniate injections and intralesional meglumine antimoniate injections alone in the treatment of cutaneous leishmaniasis due to Leishmania major: A randomized assessor-blind controlled clinical trial 2008-09-09 anticipated 210 Complete https://irct.ir/trial/338 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Cutaneous leishmaniasis. Group 1-Weekly intralesional injection of meglumine antimoniate (Glucantime, Rhodia Laboratories, rhone Polenc, France) up to six consecutive weeks or complete healing of the lesion Group/2-Weekly intralesional injection of meglumine antimoniate (Glucantime, Rhodia Laboratories, Rhone Polenc, France) up to six consecutive weeks or complete healing of the lesion plus every other day application of an inert dressing (Atrauman, Hartmann CMC Consumer Medical Care GmbH, Heidenheim, Germany) on each lesion for six consecutive weeks or complete healing/Group 3-Weekly intralesional injection of meglumine antimoniate up to six consecutive weeks or complete healing of the lesion plus every other day application of a silver containing (Atrauman Ag, Hartmann CMC Consumer Medical Care GmbH, Germany, Heidenheim, Germany) dressing on each lesion for six consecutive weeks or complete healing.
public Alireza Firooz, MD
No 79, Taleqani Avenue
Tehran Iran (Islamic Republic of) 14166-13675 +98 21 8897 8190 firozali@sina.tums.ac.ir Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences scientific Alireza Firooz, MD
No 79, Taleqani Avenue
Tehran Iran (Islamic Republic of) 14166-13675 +98 21 8897 8190 firozali@sina.tums.ac.ir Center for Resarch and training in Skin Diseases and Leprosy, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: a) Parasitollogically proven cases of cutaneous leishmaniasis based on positive smear and/or culture b) Otherwise healthy subjects on the basis of medical history c)Age: 12-60 years d) willing to participate in the study and sign the informed consent (by the patient or his/her/partner/guardian) in case of younger than 18 years Exclusion criteria: a) Pregnant or lactating women b) Duration of lesions more than 3 months c) Number of lesions more than 5 d) Ulcer size greater than 5 cm in the largest diameter e) History of full course of standard treatment (antimonials) f) History of allergy to meglumine antimoniate or silver g) Serious systemic illnesses as judged by the physician h) Participation in any drug trial in the last 60 days i) Indication for administration of systemic treatment with meglumine antimoniate j) Presence of secondary bacterial infection of the lesion according to clinical appearance of the lesion 12 years 60 years Both Group 1-Weekly intralesional injection of meglumine antimoniate (Glucantime, Rhodia Laboratories, rhone Polenc, France) up to six consecutive weeks or complete healing of the lesion Group/2-Weekly intralesional injection of meglumine antimoniate (Glucantime, Rhodia Laboratories, Rhone Polenc, France) up to six consecutive weeks or complete healing of the lesion plus every other day application of an inert dressing (Atrauman, Hartmann CMC Consumer Medical Care GmbH, Heidenheim, Germany) on each lesion for six consecutive weeks or complete healing/Group 3-Weekly intralesional injection of meglumine antimoniate up to six consecutive weeks or complete healing of the lesion plus every other day application of a silver containing (Atrauman Ag, Hartmann CMC Consumer Medical Care GmbH, Germany, Heidenheim, Germany) dressing on each lesion for six consecutive weeks or complete healing Complete healing. Timepoint: at 6 weeks after initiation of the intrvention(s). Method of measurement: Lesions' assessment of healing by measuring the size of induration and ulcer. Complete healing. Timepoint: at 6 months after initiation of the intervention(s). Method of measurement: Lesions' assessment of healing by measuring the size of induration and ulcer. Adverse Effects. Timepoint: Recorded at each follow-up visit. Method of measurement: Taking medical history and performing physical examination. CSG Trial No. 51 Cochrane Skin Group Tehran University of Medical Sciences Approved 2007-11-30 Ethical Committee of the Center for Research and Training in Skin Diseases and Leprosy, Tehran Unive No. 79, Taleqani Avnue Tehran Iran (Islamic Republic of)