on-cultured epidermal cell suspension (vitiligo surgery) plus Tofacitinib versus Non-cultured epidermal cell suspension (vitiligo surgery) alone in vitiligo
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2024/08/072025
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult (18-65 years) patients with non-segmental (generalized, acrofacial, focal) slowly progressive vitiligo or clinically stable for less than 1 year (0-9 months)
2.Vitiligo patch of size 2.5-25 cm2, that is unresponsive or partially responsive to medical treatment x more than 3 months
1.Patients with segmental vitiligo
2.Patients with vitiligo of clinical disease stability more than 1 year
3.Patients with rapidly progressive vitiligo (more than 5 patches in the last one month and/or more than 15 patches in last 3 months)
4.Patients with keloidal or bleeding tendency
5.Patients on topical treatment for last 2 weeks, and on phototherapy or systemic treatment for last 4 weeks
6.Patients with concomitant inflammatory skin diseases or autoimmune diseases requiring systemic immunosuppressive treatment
7.Patients with active or latent tuberculosis or other systemic infection or any other contra-indication to tofacitinib (as per investigators judgement)
8.Children, adults (more than 65 years), pregnant or lactating women with vitiligo
9.Women of child bearing potential not willing to observe sexual abstinence or use contraceptive during the period of oral treatment and 6 weeks beyond
10.Vitiligo patch less than 2.5cm2 or more than 25cm2 size
11.Patches on sites such as palms, soles, fingers and toes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method