Randomized Controlled Placebo Clinical Trial for the Evaluation of Antimonial Therapy and 5% Imiquimod (Aldara®) as a first-line therapy in patients without a prior history of antimonial therapy and with a diagnosis of cutaneous leishmaniasis

DRUGS FOR NEGLECTED DISEASE INITIATIVE,0 个研究点目标入组 0 人开始时间: 2005年11月21日最近更新: 2023年9月4日

试验速览

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•a) Men and women between 5 and 65 years of age.
•b) Confirmed diagnosis of cutaneous leishmaniasis (LC).
•c) No prior therapy for LC with anti-Leishmania agents.
•d) Female patients of childbearing age should have a negative urine pregnancy test, should not be breastfeeding and will need to have adequate contraception during the 20 days of treatment.
•e) They must sign the written consent or have a proxy that signs the consent of the minor in any case of a patient under 18 years of age.
•f) Residency stability or being contacted by the study team.

•a) Have an injury o injuries > 25 cm2.
•b) More than 6 skin lesions.
•c) Having a mucosal lesion.
•d) History of previous exposure to imiquimod or anti-Leishmania treatment.
•e) Participation in another experimental protocol and / or having received research products within 30 days prior to entering the study.
•f) History of an acute or chronic illness or medication that may interfere with the evaluation.
•g) History of important psychiatric illness.
•h) History of a previous severe anaphylactic reaction or severe allergic reaction to one or more of the proposed medications.
•i) Patients who are unlikely to collaborate with the
•requirements of the study protocol.
•j) Suspected concomitant infection.
•k) Women who are pregnant or breastfeeding.

发起方

DRUGS FOR NEGLECTED DISEASE INITIATIVE,