A Phase 3 interventional study of Sbv and Miltefosine plus placebo in Cutaneous Leishmaniasis, sponsored by Hospital Universitário Professor Edgard Santos. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by Hospital Universitário Professor Edgard Santos · Phase 3, Interventional, and Treatment
Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been described in up to 50% of patients, and the long period of 60 to 90 days required for healing of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited either by toxicity or because, as with Sbv, the parenteral route hinders adherence and regularity of treatment in the rural area. Recent studies by our group indicate that oral miltefosine is the most effective drug for the treatment of patients with CL caused by L. (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75% respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L. (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.
103 studies on the registry are indexed under Leishmaniasis, Cutaneous; 18 are open to participants now.
This study's enrollment of 300 is above the median of 60 across 77 interventional studies indexed under Leishmaniasis, Cutaneous.
Browse Leishmaniasis, Cutaneous studies →Hospital Universitário Professor Edgard Santos is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Meglumine antimoniate (Glucantime): Dosage: 20 mg / kg / day, intravenously, during 20 days.
Drug: Sbv
Miltefosine (28 days / 2.5mg / Kg / day at a maximum dose of 150mg / day orally) + Topical placebo (gel cream, 2 times a day for 28 days)
Drug: Miltefosine plus placebo
Miltefosine (28 days / 2.5mg / kg / day at a maximum dose of 150mg / day orally) + Topical GM-CSF (0.01% gel cream, 2 times a day for 28 days)
Drug: Miltefosine plus GM-CSF
Standard treatment for CL, parenteral drug used during 20 days.
Also known as: Glucantime
Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. Placebo gel cream will be used topically.
Also known as: Impavido plus placebo
Drug pages: Miltefosine · Granulocyte-Macrophage Colony-Stimulating Factor
Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. GM-CSF gel cream will be used topically.
Also known as: Impavido plus GM-CSF
Final cure rate or complete cicatrization of the ulcer
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. 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.
Time frame: 6 months after the end of treatment
Initial cure rate or initial cicatrization of the ulcer
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. 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.
Time frame: 2 months after the end of treatment
Healing time
Time (in days) to achieve complete cicatrization will be recorded.
Time frame: Up to 2 months after the end of treatment
Clinical and laboratory adverse events
Clinical and laboratory adverse events will be recorded and graded according to the Common Terminology Criteria for Adverse Event (CTCAE) of the National Cancer Institute
Time frame: During treatment and through study completion, an average of 1 year
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Miltefosine · Granulocyte-Macrophage Colony-Stimulating Factor
Hospital Universitário Professor Edgard Santos