Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Industrial de Santander
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
MILTEFOSINE gel
DrugEach 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.
Treatment groups
15 Participants
are divided into 3 treatment groupsGroup A: MILTEFOSINE hydrogel 0.5%Experimental treatment 1 intervention
Group B: MILTEFOSINE hydrogel 1.0%Experimental treatment 1 intervention
Group C: MILTEFOSINE hydrogel 1.5%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
End of treatment (lesion healing)
Percentage change in lesion size: Compared to baseline (the size before treatment).
Time frame
28 daysSecondary outcomes
1
Post-treatment (lesion healing or lesion reduction)
Percentage change in lesion size: Compared to baseline (the size before treatment). Lesion healing: A patient will be considered "cure" if they achieve 100% epithelialisation of the lesion (total reduction of the lesion with the presence of scar) without relapse for up to 3 months post-treatment. Therapeutic failure is defined as an increase in the lesion area to twice its initial size at the end of treatment or if the lesion does not reduce by more than 50% at three months post-treatment. Relapse is noted if, after reducing by more than 50%, the lesion enlarges again, reaching or exceeding its original size during the three months post-treatment.
Time frame
90 days2
Number and proportion of patients with adverse events, and frequency and grade of each AE (assessment of safety and tolerability to G-MTF)
The number and percentage of patients experiencing each adverse event (AE), as well as the frequency and grade of each AE, will be assessed. Throughout the treatment and follow-up period, the presence or absence of AEs at both local and systemic levels will be monitored in each of the five patients included in the G-MTF groups (G-MTF 0.5%, 1.0%, and 1.5%). Each AE will be graded on a scale from 0 to 3: * 0 indicates absence of the AE; * 1 denotes mild severity (present but not requiring treatment); * 2 indicates moderate severity (present and requiring specific treatment); * 3 signifies severe severity (present with such intensity that antileishmania therapy must be discontinued). These grades follow the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame
During treatment and after the follow up peridod (total of 4 month)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Industrial de Santander
Lead sponsor
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Collaborator
Source ClinicalTrials.gov
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