None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Sodium Stibogluconate 20 mg / kg IV / day for 20 days plus a standard dose of 5% Imiquimod cream applied to each lesion 3 times a week for 20 days, 9 applications in total.
Group name:GROUP 2 Type of group
This group will be treated with Sodium Stibogluconate 20 mg / kg IV / day for 20 days plus a standard dose of Imiquimod Placebo cream applied to each lesion 3 times a week for 20 days, 9 applications in total.
Sponsors
DRUGS FOR NEGLECTED DISEASE INITIATIVE,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Based on the size of the lesion, reduction of ulceration, re-epithelialization and reduction of inflammation. Qualifying the lesions from M0 to M4 according to scale provided by the study.. Measure:Clinical response. Timepoints:Days 1 to 20 and evaluation in months 1, 2, 3, 6, 9 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Grades 0-3 and Light-Severe. Measure:Safety and tolerability: Degree of tolerability effects. Degrees of pain in the place of application. Degree of itching Degree of erythema. Degree of edema. Timepoints:Days 1 to 20 and evaluation in months 1, 2, 3, 6, 9 and 12. | — |
Countries
Peru
Outcome results
None listed