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Leprosy clinical trials

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NCT ID: NCT06416033 Recruiting - Leprosy Clinical Trials

Serum Irisin Level In Leprosy Patients

Start date: January 1, 2024
Phase:
Study type: Observational

- Measurement of plasma irisin level in leprosy patients. - Correlation of plasma irisin level between leprosy patients and healthy controls. - Correlation of plasma irisin level in different leprosy types.

NCT ID: NCT06222372 Recruiting - Leprosy Clinical Trials

Novel Interventions and Diagnostic Tests for Leprosy

INDIGO#2
Start date: March 4, 2020
Phase: N/A
Study type: Interventional

Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting. The proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.

NCT ID: NCT05777213 Completed - Clinical trials for CM-MSC ; Stem Cell ; Trophic Ulcer ; Leprosy ; Morbun Hansen; Secretom

Potential Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)

Start date: January 1, 2019
Phase: Phase 1
Study type: Interventional

Background: Trophic ulcer is one of the complications that arise due to leprosy infection of the skin and includes diseases that trigger permanent disability and reduce the quality of life of the person. The facts in the field that more than 50% of chronic ulcers, especially trophic ulcers due to leprosy fail to heal with usual treatment. Therefore it is important to do a new method in healing trophic ulcers. Stem cell therapy or one of them is conditioned medium mesenchymal stem cell is a promising therapy because of its biological and physiological processes resembling the mechanism of wound healing Method: This research is a clinical trial research "Open Trial". Phase 1 to see the side effects caused by the intervention. Minimum sample size of 20 respondents with trophic ulcers due to leprosy that is difficult to resolve with usual treatment. The main outcome is wound healing in terms of the length and extent of the wound. The secondary outcome is treatment toxicity 4 weeks after administration. Follow-up visits will be scheduled at 2, 4, and 12 weeks post-treatment. If the results confirm safety, feasibility and potential efficacy, large multicenter randomized controlled trials with longer follow-up will begin with a focus on the effectiveness of therapy

NCT ID: NCT05597280 Recruiting - Leprosy Clinical Trials

Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy

BE-PEOPLE P3
Start date: March 22, 2023
Phase: Phase 3
Study type: Interventional

There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg/kg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.

NCT ID: NCT05406479 Completed - Leprosy Clinical Trials

Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)

BE-PEOPLE P2
Start date: July 14, 2022
Phase: Phase 2
Study type: Interventional

This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022. This new trial will be called the 'Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial. There will be two main study arms, a comparator arm based on the current WHO recommendation of providing a single dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight, to be repeated once after four weeks for household contacts. The main study will be preceded by a phase 2 safety study.

NCT ID: NCT05243654 Recruiting - Leprosy Clinical Trials

Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

MetLep
Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks. The main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.

NCT ID: NCT05091216 Completed - Xerostomia Clinical Trials

The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism.

NCT ID: NCT05047809 Completed - Wounds Clinical Trials

The Effect of "Jinchuang Ointment" (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.

Start date: August 7, 2021
Phase: N/A
Study type: Interventional

This study aimed to evaluate the effect of a Chinese herb complex "Jinchuang ointment" (JCO) on the treatment of chronic nonhealing wounds in patients with Hansen's disease and its mechanism.

NCT ID: NCT05031091 Recruiting - Hansen's Disease Clinical Trials

Epidemiology of Leprosy in French Guiana

EPI-LEPR
Start date: January 7, 2020
Phase:
Study type: Observational

The main objective of the present study is the genotyping of M. leprae strains found in leprosy patients in French Guiana. The secondary objectives are to investigate the presence of M. lepromatosis in these patients, the molecular research of M. leprae resistance to anti-leprosy antibiotics, the study of risk factors for leprosy in humans in Guyana and in particular direct or indirect contact with armadillos, as well as the determination of phylogenetic links between the M. leprae strains found in French Guiana, and with the regional and world reference strains Epidemiology of leprosy in French Guiana.

NCT ID: NCT04944498 Completed - Clinical trials for Paralytic Lagophthalmos

Modified Tarsorrhaphy vs Gold Weight Implant for Paralytic Lagophthalmos in Leprosy Patients

Start date: May 9, 2019
Phase: N/A
Study type: Interventional

This study aims to compare the effectivity and efficiency of Modified Tarsorrhaphy (MT) technique and Gold Weight Implant (GWI) technique as a surgical treatment of paralytic lagophthalmos in leprosy patients. The hypothesis is that MT technique is more effective and more efficient than GWI technique. This study used PROBE (Prospective Randomized Open-label Blinded-Endpoint) clinical trial. Samples consisted of 14 eyes in MT group and 13 eyes in GWI group as the control group. This study was conducted in 3 hospitals in Indonesia and the patients were observed in 1 year period.