CTRI/2017/03/008186Not yet recruitingPhase 4
A Study to access the efficacy of cultured pluckedhair follicle outer root sheath melanocyte fortransplantion in stable vitiligo
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- AIIMS
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Repigmentation
Study Overview
Brief Summary
Vitiligo is a common acquired depigmenting disorder with significant psychological distress. Surgical treatment is indicated for depigmented areas not responding to medical treatment in stable disease. When large surface area needs to be covered we need more no. of melanocytes. So melanocyte culture is an important modality to provide this motive. If we are able to culture melanocytes from a renewable source like plucked hair follicle it can be a major breakthrough in vitiligo research and treatment. In this study, we will try to culture melanocyte from plucked hair follicle and transplant in to patients vitiligo lesion. As a pilot study we kept sample size of 5 patients.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with clinical diagnosis of segmental or generalized vitiligo
- •Vitiligo should have been stable for at least two year or more to be included in the study.
- •The patient should have at least one large patch of 16 cm2 or more will be taken.
Exclusion Criteria
- •1.Age less than 18yrs 2.Pregnancy 3.Koebnerization 4.Keloid or bleeding diathesis 5.Active infection at the site 6.Other autoimmune diseases 7.Inability to come for follow-up for at least 6 months 8.Patients with involvement of only acral sites and bony prominences.
Outcomes
Primary Outcomes
Repigmentation
Time Frame: Repigmentation:4,8,12,16,20,24 weeks
Secondary Outcomes
- Patient’s satisfaction about the procedure(6 months)
Investigators
Study Sites (1)
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