A Study to evaluate the disease activity in Non-segmental vitiligo.

Not yet recruiting

• Conditions: Vitiligo,

• Registration Number: CTRI/2024/01/061435
• Lead Sponsor: Dr Ashwini Ashokan

Brief Summary

The objectives of this study ie immunostaining of  NLRP-1 and histopathological grading especially in the perilesional skin would be able to add significant information to the already available clinically scoring system , to obtain the progression / stability of the disease and  maybe useful in making clinical decisions  in guiding further therapeutic interventions such as performing vitiligo surgery.The study will be conducted at Amrita Institute of Medical sciences , Kochi.  The study participants are the Vitiligo patients presenting to the Dermatology OPD . Only patients who are willing to be included in the study , co-operative to the need of detailed clinical  and histopathological examination shall be enrolled for the study .

Detailed history taking and clinical examination (based on VETF scoring index ) would be conducted and subsequent classification under as either stable or un-stable vitiligo groups .The patients would be subjected to biopsy procedure, where 2 biopsy samples ie. lesional  & peri-lesional would be collected using the 4mm dermal biopsy punch .The sample would be sent for  histopathological examination and subsequent Immunohistochemistry staining using Anti-NLRP1 anti-body  immunostain. Direct evaluation and grading of the histopathological scoring using Vitiligo Histological scoring system by Yadav et al and presence & intensity of staining Anti-NLRP1 antibody  immunostaining will be done for each patient .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-27
• Study Start: 2024-01-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients presenting to the dermatology OPD with generalized/non-segmental vitiligo .

Exclusion Criteria

• 1)Segmental vitiligo 2)Non-segmental vitiligo patients who received any topical or systemic therapy in past 3 months duration.
• 3)<18 years of age 4)Associated autoimmune diseases 5)Pregnant or lactating mothers.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence of NLRP1 immunostaining in Non-segmental vitiligo and correlate the NLRP1 immuno-staining intensity with clinical activity in Non-segmental vitiligo using VETF scoring system	18 months

Secondary Outcome Measures

Name	Time	Method
To correlate the histopathological features of Non-segmental vitiligo using Vitiligo Histopathological scoring system proposed by Yadav et al with clinical activity / stability us-ing VETF scoring system.	18 months

Trial Locations

Locations (1)

Amrita Institute of Medical Sciences; 🇮🇳 Ernakulam, KERALA, India

Amrita Institute of Medical Sciences

🇮🇳Ernakulam, KERALA, India

Dr Ashwini Ashokan

Principal investigator

07353389888

ashwiniashokan97@gmail.com