Experiment for the treatment of Leishmaniasis of the skin with two drugs, Pentamidine and Tamoxifen

Treatment of American Tegumentary Leishmaniasis due to Leishmania (Viannia) guyanensis with a combination regimen of Pentamidine and Tamoxifen. Randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-7y2gbdf

Enrollment

Unknown

Registered

2023-05-11

Start date

2020-10-21

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous leishmaniasis

Interventions

Two-arm randomized controlled clinical trial. Of 126 patients evaluated, a total of 50 people met the eligibility criteria and were probabilistically allocated to one or the other group using a comput

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Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Aged from 18 to 65 years; diagnosis of Cutaneous Leishmaniasis confirmed by direct parasitological examination; with a maximum of six lesions; without previous treatment

Exclusion criteria

Exclusion criteria: Women of childbearing age not using contraceptives; pregnant; lactating women; patients who had already had leishmaniasis; presence of comorbidities; patients under treatment with immunosuppressants or drugs that prolong the QT interval; patients with difficulties in attending planned visits in the study

Design outcomes

Primary

Measure	Time frame
The primary outcome is clinical cure, defined as complete healing of all ulcers (with flattening of the edges, disappearance of the crust, scaling, infiltration or hardening of the base, erythema and lymphangitis or adenitis, if present, and absence of new lesions) in the 6th month after starting treatment. According to the time of evaluation, cases will be classified into: partial healing, that is incomplete healing of one or more lesions and absence of new lesions in the follow-up, up to 3 months after the start of treatment; initial healing with complete epithelialization of all ulcers, up to 3 months after starting treatment; treatment failure, defined as failure to completely epithelialize the lesions within 6 months of treatment, or if the lesions worsen or if a new lesion appears at any time	—

Measure

Time frame

The primary outcome is clinical cure, defined as complete healing of all ulcers (with flattening of the edges, disappearance of the crust, scaling, infiltration or hardening of the base, erythema and lymphangitis or adenitis, if present, and absence of new lesions) in the 6th month after starting treatment. According to the time of evaluation, cases will be classified into: partial healing, that is incomplete healing of one or more lesions and absence of new lesions in the follow-up, up to 3 months after the start of treatment; initial healing with complete epithelialization of all ulcers, up to 3 months after starting treatment; treatment failure, defined as failure to completely epithelialize the lesions within 6 months of treatment, or if the lesions worsen or if a new lesion appears at any time

—

Secondary

Measure	Time frame
Secondary outcomes are adverse effects characterized by the presence of signs or symptoms related to drug use, classified as: mild, if tolerated, without symptomatic drug interference or discontinuation of specific therapy; moderate, when tolerated with the use of symptomatic medication; severe, when it cannot be circumvented, except with the suspension of the specific medication	—

Countries

Brazil

Contacts

Public ContactSilmara Pennini

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

pennini.sn@gmail.com+55(92)981121660

Outcome results

None listed

Source: REBEC (via WHO ICTRP)