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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04072874
Recruitment Status : Suspended (Tthe study is in the approval phase by local regulatory authorities)
First Posted : August 28, 2019
Last Update Posted : November 30, 2020
Sponsor:
Collaborators:
INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)
Comprehensive Strategy for the Control of Leishmaniasis in Colombia
Information provided by (Responsible Party):
Ivan Darío Vélez Bernal MD. MSc.. PhD., Universidad de Antioquia

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.


Condition or disease Intervention/treatment Phase
Leishmaniasis, Cutaneous Drug: Experimental topical (Curaleish Topical) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Clinical Activity of Curaleish Lotion and Cream in the Topical Treatment of Cutaneous Leishmaniasis in Colombia
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
Active Comparator: Régimen 1
  • 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)
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.
Other Name: Curaleish Topical

Active Comparator: Régimen 2
  • 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)
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.
Other Name: Curaleish Topical




Primary Outcome Measures :
  1. post treatment (healing) [ Time Frame: day 180 ]

    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.



Secondary Outcome Measures :
  1. 2. Days 28 and 42, respectively, depending on the duration of each treatment group. (Adverse events) [ Time Frame: 28 days and 42 days ]

    Adverse events (AEs) will be evaluated according to the seriousness, temporal relationship, relationship with the study medication, and severity. The recording will be carried out through clinical examination, telephone calls, and through the completion of the subject's diary.

    The local AEs that will be evaluated are:

    1. Erythema
    2. Burning
    3. Pain
    4. Pruritus
    5. Irritation

    The following evaluations will be made:

    • Frequency and severity (Mild, Moderate, Severe) of AEs by treatment group.
    • Status (area of lesions, induration, erythema, etc.) in each measurement. Additionally, before starting treatment and at the end of it, renal (creatinine) and liver function (transaminases) tests will be performed on volunteers.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072874


Locations
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Colombia
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, Colombia, 1226
Sponsors and Collaborators
Universidad de Antioquia
INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)
Comprehensive Strategy for the Control of Leishmaniasis in Colombia
Investigators
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Principal Investigator: Ivan D Velez Director PECET
Publications:
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.
Pearson, R. D., and A. de Querez Sousa. 1995 Leishmania species: visceral (kala-azar), cutaneous, and mucosal leishmaniaisis. p. 2428-2442. In G. L. Mandell, J. E. Bennett, and R. Dolin (ed.) Principles and practice of infectious diseases. Churchill Livingstone, New York, N.Y.
Organizacion Panamerica de la Salud, OPS. Leishmaniasis en las Americas: Recomendaciones para el tratamiento. 2013. http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=22226&Itemid

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Responsible Party: Ivan Darío Vélez Bernal MD. MSc.. PhD., Full professor Faculty of Medicine - PECET, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT04072874    
Other Study ID Numbers: PEC02_2019
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan Darío Vélez Bernal MD. MSc.. PhD., Universidad de Antioquia:
Leishmaniasis
Curaleish
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Infections
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases