Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis.

NCT04072874 | Withdrawn Phase 1

• 1 other identifier: PEC02_2019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous Leishmaniasis (CL) is a parasitic disease caused by more than 15 different species of the protozoan parasite Leishmania. The CL usually begins with a papule at the site of the sandfly bite, increasing in size to form a nodule that ulcerates in a period of 1 to 3 months. The exact incidence of CL is not known. An estimated 1.2 million cases/year in approximately 102 countries worldwide suffer from different forms of CL. Among the different parasites that cause CL, L.tropica in the Old World and L.braziliensis in the New World are considered to be the most important due to the difficulty of healing, the public importance and the severity of the disease. Pentavalent antimony remains the first choice drug for the treatment of CL and the evidence to support its use is sometimes based on qualitative, retrospective and uncontrolled observations, with only some controlled clinical studies. Antimonials are widely used despite their toxicity, difficulty in the route of administration, and high cost. Miltefosine (hexadecylphosphocholine), an oral medication that has proven effective for some types of Leishmania, is potentially teratogenic, is contraindicated during pregnancy and requires appropriate counseling for female patients of childbearing age.

Conditions

Leishmaniasis, Cutaneous

Keywords

Leishmaniasis; Curaleish

Outcome Measures

Primary Outcomes (1)

• post treatment (healing)

  Healing: initial healing \* without relapse and/or mucous commitment for the post-treatment evaluation of Day 180. \*Initial healing: defined as 100% re-epithelialization of the lesion(s) following Day 90 post-treatment.

  day 180

Secondary Outcomes (1)

• 2. Days 28 and 42, respectively, depending on the duration of each treatment group. (Adverse events)

  28 days and 42 days

Study Arms (2)

Régimen 1

ACTIVE COMPARATOR

* Regimen 1: Curaleish lotion applied three times a day in combination with Curaleish cream applied two times a day for 4 weeks. * For both treatments, the patient applies Curaleish lotion in the morning, afternoon, and evening, that is to say, three times a day. And Curaleish cream in the morning and afternoon, that is, twice a day.

Drug: Experimental topical (Curaleish Topical)

Régimen 2

ACTIVE COMPARATOR

* Regimen 2: Curaleish lotion applied three times a day in combination with Curaleish cream applied two times a day for 6 weeks. * For both treatments, the patient applies Curaleish lotion in the morning, afternoon, and evening, that is to say, three times a day. And Curaleish cream in the morning and afternoon, that is, twice a day.

Drug: Experimental topical (Curaleish Topical)

Interventions

Experimental topical (Curaleish Topical) DRUG

Curaleish is a formulation in lotion and cream. Curaleish lotion and Curaleish cream will be applied topically by each participant in all lesion until day 28 or 42, depending on the regimen to be evaluated. Study staff will be closely observing the safety assessment. The application until Day 28 or 42 will continue, even if the lesion has shown 100% re-epithelization before day 28 or day 42.

Also known as: Curaleish Topical

Régimen 1; Régimen 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between 18 - 60 years.
• Patient with confirmed parasitological diagnosis of CL in at least one lesion, performed at least through the following methods: 1) microscopic identification of amastigotes in tissue of the lesion; 2) Leishmania diagnose through PCR; 3) positive culture for promastigotes.
• Patient with a lesion that meets the following criteria:
• Ulcer or nodule with a maximum size of 4 cm (the largest diameter).
• Not located in the ear, face, near mucous membranes, joints, or in places that, in the opinion of the PI, the study medication is difficult to apply topically.
• Patient with a maximum of four CL lesions.
• The duration of the lesion is less than three months according to the patient's history.
• The patient is able to give written informed consent.
• Patients whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol.

You may not qualify if:

• Patients who meet some of the following criteria must be excluded from the study:
• Women with positive pregnancy test during the screening process, or who are lactating; or women of childbearing age who do not agree to take contraceptives during treatment and until Day 45.
• The subject has a history of significant medical conditions or treatments that may interact negatively or positively with the topical treatment of Leishmaniasis, including any immune compromise condition.
• Within eight weeks (56 days) of beginning the study treatments, having received treatment for Leishmaniasis through any medication, including Glucantime that probably, in the opinion of the principal investigator (PI), might modify the course of the infection by Leishmania.
• Based on physical examinations performed, they have been diagnosed, or a diagnosis of Mucocutaneous Leishmaniasis is suspected.
• Known history or suspected hypersensitivity or idiosyncratic reactions to the study medication.
• Patients who do not wish to attend study appointments or who cannot keep up with follow-up visits for up to 6 months

Sponsors & Collaborators

• Universidad de Antioquia: lead
• INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO): collaborator
• Comprehensive Strategy for the Control of Leishmaniasis in Colombia: collaborator

Study Sites (1)

Program for Research and Control in Tropical Diseases - PECET

Medellín, Antioquia, 1226, Colombia

Location

Related Publications (18)

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• Soto J, Rea J, Balderrama M, Toledo J, Soto P, Valda L, Berman JD. Efficacy of miltefosine for Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg. 2008 Feb;78(2):210-1.

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• WHO technical report series; no. 949. Control of the leishmaniasis: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22-26 March 2010.

  BACKGROUND

• Silva NS, Muniz VD. [Epidemiology of American tegumentary leishmaniasis in the State of Acre, Brazilian Amazon]. Cad Saude Publica. 2009 Jun;25(6):1325-36. doi: 10.1590/s0102-311x2009000600015. Portuguese.

  PMID: 19503963 BACKGROUND

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  BACKGROUND

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• Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.

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  BACKGROUND

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MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Leishmaniasis

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ivan D Velez

  Director PECET

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor Faculty of Medicine - PECET

Model Details: An Open-label, Randomized, Non-comparative, Two-arm Exploratory study. After all the screening evaluations have been completed, the principal investigator or his designee will confirm the patient's eligibility on Day 1, and the randomization will be determined by IWRS where randomized identification of the patient will be provided. The treatment allocation will be performed according to a computer-generated random code.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: January 1, 2021
• Primary Completion: February 1, 2021
• Study Completion: July 1, 2022
• Last Updated: June 3, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)