None listed
Conditions
Interventions
Both Imiquimod and placebo will have the same presentation, smell or taste and will be administered on an outpatient basis. At each opportunity, one of the Investigators will apply directly to the lesion or lesions, the cream under study (Imiquimod at 5% or placebo), interdiario for six weeks. The cream will be applied in and around the injury and you will be observed to! patient a period of at least 30 minutes to prevent the cream from being removed.
Group name:Control Type of group
Both Imiquimod and placebo will have the same presentation, smell or taste and will be administered on an outpatient basis. At each opportunity, one of the Investigators will apply directly to the lesion or lesions, the cream under study (Imiquimod at 5% or placebo), interdiario for six weeks. The cream will be applied in and around the injury and you will be observed to! patient a period of at least 30 minutes to prevent the cream from being removed.
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients with cutaneous leishmaniasis with parasitological demonstration, (2) Both sexes, (3) Age: 14 years or older.
Exclusion criteria
Exclusion criteria: (1) Under 14 years old, (2) Injuries located on the face or on joints, (3) Injuries with areas larger than 25 cm (4) Pregnant women or women who are breastfeeding (the first three months), (5) Be carriers of a systemic disease, (1) Guests immuno compromised
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The local reaction will be used to evaluate the safety with respect to the inflammation (the induration area will be recorded and measured in a piece of plastic to obtain the exact size) and to the erythema (area of redness that will be recorded by the doctor during the treatment and at control visits on days 14, 28, 56 and 98 and at 6 months). The discomfort will be quantified daily with a subjective scale reported by the patient. Measure:Safety Timepoints:During the treatment and at control visits on days 14, 28, 56 and 98 and at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:- The parasitological cure is defined as the absence of parasites established by a negative microscope slide and the inability to cultivate promastigotes of aspirates or scrapes. The moment of parasitological cure will be registered as the first opportunity during which no parasite could be cultivated in the following periods 14, 28, 56 or 98 days, 6 months. Measure:Efficacy Timepoints:14, 28, 56 or 98 days, 6 months. ; Outcome name:The clinical cure is defined as the complete healing of the lesion demonstrated by re-epithelialization of the lesion with disappearance of the scab and inflammation. The time of clinical cure will be recorded as the first visit during which these changes were documented in the following periods 14, 28, 56 or 98 days, 6 months. Measure:Efficacy Timepoints:14, 28, 56 or 98 days, 6 months. | — |
Countries
Peru
Outcome results
None listed