NCT01923142

Efficacy of Autologous Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Centro Studi Gised · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.

Conditions

• Vitiligo

Interventions

Type	Name	Description
BIOLOGICAL	Outer-Root-Sheath Melanocytes Suspension	The treatment consists in depositing a suspension of autologous outer-root-sheath melanocytes, derived from patient's plucked hair follicles, and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).
BIOLOGICAL	Placebo	The treatment consists in depositing a solution made of saline and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-08-15
• Last updated: 2016-01-27

Locations

2 sites across 1 country: Italy