Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00600548 | Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil) | PHASE2 | COMPLETED | 180 | — | — | Jul 1, 2007 | Jul 1, 2009 | Apr 15, 2010 | 2 | Brazil |
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
| Arm | Type | Description |
|---|---|---|
| 1.1 | EXPERIMENTAL | Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine. |
| 1.2 | ACTIVE_COMPARATOR | Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment). |
| 2.1 | EXPERIMENTAL | Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine. |
| 2.2 | ACTIVE_COMPARATOR | Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment). |
| Name | Type | Description |
|---|---|---|
| Miltefosine. | DRUG | Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day. |
| Meglumine antimoniate. | DRUG | Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day. |
Inclusion Criteria: * Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test). * Number of lesions: 1 ...