NCT07149753

Brief Summary

The goal of this clinical trial is to learn if the drug MILTEFOSINE, used topically in a hydrogel, works to treat non-complicated cutaneous leishmaniasis (CL) in adults. It will also learn about the safety of the drug MILTEFOSINE used topically. The main questions it aims to answer are:

  • Is topical treatment with MILTEFOSINE hydrogel effective in patients with CL, thus justifying its continuation in the clinical phases (II and III) of development?
  • What skin problems do participants have when using miltefosine hydrogels over CL lesions? Researchers will evaluate the safety and effectiveness of various concentrations of MILTEFOSINE hydrogel: 0.5%, 1.0%, and 1.5%. Participants will:
  • Apply the MILTEFOSINE hydrogel to the affected lesions daily for 28 consecutive days.
  • Visit the Center at least two days prior to the study. This initial visit will include diagnostic tests, interviews, study information, informed consent, and the administration of the first doses. After this, patients are required to return to the clinic on day 28 and again three months later for additional check-ups and tests.
  • Take a photo once a week for checkups, and keep a note of their symptoms

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
4mo left

Started Jan 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

August 16, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 16, 2025

Last Update Submit

August 30, 2025

Conditions

Cutaneous LeishmaniasisCutaneous Leishmaniasis, AmericanTopical Administration

Keywords

cutaneous leishmaniasistopical treatmentmiltefosinehydrogel

Outcome Measures

Primary Outcomes (1)

  • End of treatment (lesion healing)

    Percentage change in lesion size: Compared to baseline (the size before treatment).

    28 days

Secondary Outcomes (2)

  • Post-treatment (lesion healing or lesion reduction)

    90 days

  • Number and proportion of patients with adverse events, and frequency and grade of each AE (assessment of safety and tolerability to G-MTF)

    During treatment and after the follow up peridod (total of 4 month)

Study Arms (3)

MILTEFOSINE hydrogel 0.5%

EXPERIMENTAL

MILTEFOSINE hydrogel 0.5% topically daily for 28 days

Drug: MILTEFOSINE gel

MILTEFOSINE hydrogel 1.0%

EXPERIMENTAL

MILTEFOSINE hydrogel 1.0% topically daily for 28 days

Drug: MILTEFOSINE gel

MILTEFOSINE hydrogel 1.5%

EXPERIMENTAL

MILTEFOSINE hydrogel 1.5% topically daily for 28 days

Drug: MILTEFOSINE gel

Interventions

MILTEFOSINE gelDRUG

Each patient will receive a 30 g tube of G-MTF with instructions and recommendations for use. The first dose will be in the FOSCAL clinical studies unit; subsequent doses will be applied at the patient's site of origin based on their autonomy, once a day (morning or night). Instructions include washing hands thoroughly, cleaning the lesion, applying a thin layer of gel, leaving it uncovered for at least 15 minutes, avoiding contact with water until the next dose, and storing the gel properly during treatment.

Also known as: topical miltefosine
MILTEFOSINE hydrogel 0.5%MILTEFOSINE hydrogel 1.0%MILTEFOSINE hydrogel 1.5%

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of confirmed cutaneous leishmaniasis (CL)
  • Age: 18 - 65 years.
  • Patients who have 1-4 CL skin lesions with a diameter of 1-4 cm, with an evolution time of more than one month and not located on the face, ears, or joints.
  • Patients WITHOUT suspected complicated CL (large regional lymphadenopathy, several large lesions spread to different parts of the body); NO mucosal leishmaniasis and NO suspicion of unusual leishmaniasis syndromes (e.g., recurrent leishmaniasis, diffuse or disseminated CL).
  • Patients with NO history of systemic antileishmania treatment within 8 weeks prior to starting the study.
  • Patients WITHOUT treatment failure with local therapy (intralesional antimonial injections or thermotherapy) or systemic therapy.

You may not qualify if:

  • Pregnant or lactating women; women of reproductive age who refuse to use contraception until 45 days after treatment ends.
  • Patients with cardiovascular, hepatic, or renal impairment or who report underlying diseases that medically compromise their participation in this study.
  • Patients who report a history of immunodeficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calle 158 No. 20-95 Cañaveral

Floridablanca, Santander Department, Colombia

Location

Related Publications (8)

  • Neira LF, Mantilla JC, Escobar P. Monitoring cutaneous leishmaniasis lesions in mice undergoing topical miltefosine treatment. Sci Pharm. 2023; 91(4):54. https://doi.org/10.3390/scipharm91040054

    BACKGROUND

  • Neira LFb., Peña DP., Vera AM., Mantilla JC., Escobar P. Leishmaniasis cutánea inducida por especies de Leishmania Viannia en ratones BALB/c y eficacia de un tratamiento tópico. Rev Univ Ind Santander. Salud. 2019 Mar;51(1):33-42.doi.org/10.18273/ revsal.v51n1-2019004

    BACKGROUND

  • Neira LF, Mantilla JC, Escobar P. Anti-leishmanial activity of a topical miltefosine gel in experimental models of New World cutaneous leishmaniasis. J Antimicrob Chemother. 2019 Jun 1;74(6):1634-1641. doi: 10.1093/jac/dkz049.

    PMID: 30815688BACKGROUND

  • Escobar P, Yardley V, Croft SL. Activities of hexadecylphosphocholine (miltefosine), AmBisome, and sodium stibogluconate (Pentostam) against Leishmania donovani in immunodeficient scid mice. Antimicrob Agents Chemother. 2001 Jun;45(6):1872-5. doi: 10.1128/AAC.45.6.1872-1875.2001.

    PMID: 11353640BACKGROUND

  • Castro MD, Gomez MA, Kip AE, Cossio A, Ortiz E, Navas A, Dorlo TP, Saravia NG. Pharmacokinetics of Miltefosine in Children and Adults with Cutaneous Leishmaniasis. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e02198-16. doi: 10.1128/AAC.02198-16. Print 2017 Mar.

    PMID: 27956421BACKGROUND

  • Blum J, Lockwood DN, Visser L, Harms G, Bailey MS, Caumes E, Clerinx J, van Thiel PP, Morizot G, Hatz C, Buffet P. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. Int Health. 2012 Sep;4(3):153-63. doi: 10.1016/j.inhe.2012.06.004.

    PMID: 24029394BACKGROUND

  • Aronson N, Herwaldt BL, Libman M, Pearson R, Lopez-Velez R, Weina P, Carvalho E, Ephros M, Jeronimo S, Magill A. Diagnosis and Treatment of Leishmaniasis: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Am J Trop Med Hyg. 2017 Jan 11;96(1):24-45. doi: 10.4269/ajtmh.16-84256. Epub 2016 Dec 7. No abstract available.

    PMID: 27927991BACKGROUND

  • Andrade HM, Toledo VP, Pinheiro MB, Guimaraes TM, Oliveira NC, Castro JA, Silva RN, Amorim AC, Brandao RM, Yoko M, Silva AS, Dumont K, Ribeiro ML Jr, Bartchewsky W, Monte SJ. Evaluation of miltefosine for the treatment of dogs naturally infected with L. infantum (=L. chagasi) in Brazil. Vet Parasitol. 2011 Sep 27;181(2-4):83-90. doi: 10.1016/j.vetpar.2011.05.009. Epub 2011 May 14.

    PMID: 21641721BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, CutaneousLeishmaniasis, Mucocutaneous

Interventions

miltefosine

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cristian Blanco, PhD

    Universidad Industrial de Santander

    STUDY CHAIR

Central Study Contacts

Patricia Escobar, PhD

CONTACT

+573123160985pescobar@uis.edu.co

JAIME A GOMEZ, MD, IM

CONTACT

57 607 7000 300jgomez608@unab.edu.co

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

August 16, 2025

First Posted

September 2, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)