A study to assess if molecular analysis of certain leprosy specific genes shall be helpful in monitoring response to therapy in leprosy

Recruiting

• Conditions: Other specified local infections of the skin and subcutaneous tissue,

• Registration Number: CTRI/2017/11/010609
• Lead Sponsor: IADVL Research Grants

Brief Summary

This is a prospective clinical study to compare the baseline and post treatment RT-PCR quantifiucation values of 16S RNA and 18kDa antigen gene targets in leprosy patients. Fifty consecutive  newly diagnosed untreated  Hansen’s disease patients coming to our hospital during the study period shall be recruited for the study. Baseline Slit skin smear for Baceriological and morphological index, skin biopsy for histopathalogy and molecular analysis shall be done. All patients shall be started on Multidrug therapy for Leprosy as per WHO guidelines. Skin smear and skin biopsy for RT-PCR analysis shall be repeated at 6 and 12 months of therapy in patients with positive baseline values.  Hypothesis: RT-PCR analysis of strength of expression of 16 S RNA and 18 kDa gene expression is effective  in monitoring response to therapy in Leprosy.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-12
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All newly diagnosed untreated Hansen’s disease patients coming to the dermatology out-patient department of our hospital dyring the study period.

Exclusion Criteria

i) Hansen’s disease patients on treatment or those who have completed treatment ii) Doubtful cases not confirmed by biopsy or SSS iii) Cases of pure neuritic Hansen’s disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
strength of expression of 16S RNA and 18 kDa antigen genes	Baseline at 6 and 12 months of multidrug therapy
Morphological index	Baseline at 6 and 12 months of multidrug therapy

Secondary Outcome Measures

Name	Time	Method
1.To assess the change in RT-PCR expression of 16S RNA and 18-kDa genes in skin biopsy specimens at 6 and 12 months of chemotherapy.	2.To compare the percentage change in RT-PCR values of 16S RNA and 18-kDa genes with percentage reduction in Morphological index at 6 and 12 months post treatment in smear positive patients

Trial Locations

Locations (1)

JSS Hospital; 🇮🇳 Mysore, KARNATAKA, India

JSS Hospital

🇮🇳Mysore, KARNATAKA, India

Ranugha PSS

Principal investigator

9880375157

ranughapss@jssuni.edu.in