Clinical Trial: Comparison of the Efficacy of Micro-holes vs. Laser-assisted Dermabrasion, for Repigmenting in Vitiligo Skin
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Comparison of the Efficacy of Micro-holes vs. Laser-assisted Dermabrasion, for Repigmenting in Vitiligo Skin
Brief Summary:
Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo.
A total of 10 patients with stable non-segmental vitiligo will be included in the ITT population.
In each patient, three separate test areas will be selected in the same part of the body.
One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension alone and the two others will receive the epidermal cell suspension in hyaluronic acid after pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his own control.
Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week after cell grafting.
Detailed Summary:
Condition Stable lesion of Vitiligo of adulthood
Background Laser-assisted dermabrasion is the gold standard for preparing the grafting bed of epidermal suspension but it requires a technical platform and a trained physician. Side effects are not uncommon. We have demonstrated in an ex vivo study that micro-needles create holes in the epidermis allowing cells to reach the lower layers of the epidermis. We hypothesize that the use of micro-needles could be an effective and easy technique for preparing the grafting bed for epidermal suspensions.
Objectives Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo.
The secondary objectives are
- To evaluate and compare the tolerability of the distinct procedures
- To evaluate the global satisfaction of patient and the willingness to reproduce the procedure for treating other areas
- To evaluate the contrast between treated skin and perilesional area
Methods Prospective, multicentre, randomized, controlled, blind assessor trial.
Inclusion criteria
- Men and women aged over 18 years old with a diagnosis of non-segmental lesions that has been stable over three months
- The minimum distance between the normal pig
Sponsor: Centre Hospitalier Universitaire de Nice
Current Primary Outcome: Rate of repigmentation lesions [ Time Frame: at 3 months ]
Rate of repigmentation lesions at 3 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Global satisfaction expressed by the patient [ Time Frame: at 3 months ]Global satisfaction expressed by the patient per treated area at the end of the treatment
- EVA scale [ Time Frame: During the procedure ]Pain expressed by the patient during the procedure (EVA scale)
- -Contrast between treated and perilesional area (Nottingham scale) [ Time Frame: at 3 months ]Contrast between treated and perilesional area (Nottingham scale)
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Nice
Dates:
Date Received: January 4, 2016
Date Started: February 2016
Date Completion: December 2018
Last Updated: March 30, 2017
Last Verified: March 2017
- Global satisfaction expressed by the patient [ Time Frame: at 3 months ]
