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Also known as Impavido.
Miltefosine · 1 trial · 1 indication
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 ...
Miltefosine is being studied for the treatment of cutaneous leishmaniasis in Brazil. It is a small molecule therapeutic being developed by COSCIENS Biopharma Inc. for this parasitic skin infection. The program is in Phase 2 clinical development.
Miltefosine is being developed by COSCIENS Biopharma Inc., which trades under the ticker CSCI. The company is advancing the small molecule for cutaneous leishmaniasis in Brazil.
Miltefosine is in Phase 2 clinical development. It is investigational and has not been approved for the treatment of cutaneous leishmaniasis in Brazil. One Phase 2 trial has been completed.
Miltefosine has been evaluated in one completed Phase 2 trial, NCT00600548, titled Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil). The trial enrolled 180 participants in Brazil, was randomized and active-controlled, and included patients aged 2 years and older.
Miltefosine is also known simply as miltefosine. The drug is a small molecule being developed by COSCIENS Biopharma Inc. for cutaneous leishmaniasis in Brazil.