Cutaneous Leishmaniasis
Conditions
Brief summary
This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.
Interventions
DRUGImiquimod
Sponsors
Drugs for Neglected Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males/Females between 5 and 65 yrs * CL diagnosis confirmed * \>4 weeks time disease * no prior anti-leishmanial therapy for CL * negative pregnancy test * informed written consent or parent consent for \<18yrs patients
Exclusion criteria
* \>25cm2 lesion(s) * \>6 cutaneous lesions * mucosal lesion * previous exposure to Imiquimod or anti-leish treatment * participation in another protocol within 30 days prior study * other acute or chronic illness / medication that may interfere * significant psychiatric illness * anaphylaxis or severe allergic reaction to proposed drugs * patients unlikely to cooperate * concomitant infection * pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to healing | — |
| Reduction of scaring | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (measured by AE reporting) during treatment and follow up to 12 months | — |
Countries
Peru
Outcome results
None listed