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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
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).
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).
Papa Giovanni XXIII Hospital
Bergamo, Italy
Spedali Civili
Brescia, Italy
Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis
Time frame: 12 weeks
Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale
Time frame: 6 weeks, 12 weeks
Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale
Time frame: 6 weeks, 12 weeks
Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale
Time frame: 6 weeks, 12 weeks
Any repigmentation of the treated areas from baseline as assessed by image analysis
Time frame: 6 weeks, 12 weeks
Any repigmentation of other areas affected by vitiligo from baseline as assessed by physician according to an ordinal 6-points scale (evaluation of a possible systemic effect)
Time frame: 6 weeks, 12 weeks
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