Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients

NCT06819449 | Recruiting DMC

• 1 other identifier: Rab 32 gene polymorphisms
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Mycobacterium leprae is a slow-growing bacillus that causes leprosy. the infection may take two to ten years to incubate. While the exact mechanism of infection transmission is unknown, direct bacillus absorption through the nasal or respiratory mucosa and aerosolized nasal secretions are the most common theories. The bacteria is subsequently transported by the bloodstream to the peripheral nerves, where it can result in tissue damage from painless burns and ulcers as well as irreparable nerve damage that results in a loss of protective feeling.

Conditions

Leprosy; Mycobacterium Leprae Infection

Outcome Measures

Primary Outcomes (1)

• Treatment of leprosy

  About 40 of Participants With Treatment-Related Adverse Events as Assessed by measuring the of Rab 32 gene ( Rs2275606 ) polymorphism using real time PCR for Evaluation of the multi drug therapy on Leprotic Patients

  6 Months

Study Arms (2)

Group A: Leprosy Patients

ACTIVE COMPARATOR

About 40 patients suffering from Leprosy and will treated by Multi drug therapy as ( dapsone \_ clofazimine \_ rifampcin) then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant At the end of third month therapy.

Drug: Dapsone

Group B: Healthy People

ACTIVE COMPARATOR

About 10 Healthy People. no drugs used and then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant

Drug: Dapsone

Interventions

Dapsone DRUG

To evaluate the effect of the multi drug therapy in leprotic patients and their side effects and to assess the role of Rab 32 gene in leprosy prognosis and to know its association with the multi drug therapy.

Also known as: clofazimine, rifampcin

Group A: Leprosy Patients; Group B: Healthy People

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of both sexes with positive slit skin smear for m.leprae .

You may not qualify if:

• Contraindications to Multi drug therapy :
• Patients with hypersensitivity to sulfa .
• Patients with hypersensitivity to clofazimine or rifampcin.
• pregnant or lactating women.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qina University hospital, South Valley University Hospital

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Leprosy

Interventions

Dapsone; Clofazimine

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Phenazines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eisa Mohammed Hegazy, Assist. Prof

  Dermatology, Venereology and Andrology. Faculty of Medicine,South Valley University

  STUDY CHAIR

Central Study Contacts

Lydia Atef Nassief, MSc

CONTACT

+201289416276; lydiaatef67@gmail.com

Eisa Mohammed Hegazy, Assist. Prof

CONTACT

+201094337795; eisa_mohamed4152@med.svu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Dermatology , venereology and andrology at Faculty of medicine

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 11, 2025
• Study Start: December 20, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 20, 2025
• Last Updated: February 11, 2025

Record last verified: 2024-12

Locations

EG (1)