Clinical Trials Directory

Trials / Completed

CompletedNCT01087216

Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

The treatment of vitiligo remains disappointing especially in some localization such as bony prominences and extremities. The association of UVB and topical steroids has been proven to be synergistic but the results are still insufficient in those difficult to treat areas. Promising results have been shown with the combination of laser assisted dermabrasion, topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin followed by topical steroids should potentialized the effect of UVB and be superior to topical steroids and UVB without dermabrasion. The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion combined to topical steroids and UVB phototherapy in difficult to treat areas. Patients with symmetrical non segmental vitiligo will be included in this prospective randomized monocentrer study. The investigators calculated the number of patients needed at 25. The side that will receive the dermabrasion will be centrally randomized and the opposite side will serve as control. Then on both side class 3 topical steroids will be applied daily 3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks. The evaluation will be performed by two independent physician blinded to the treatment of standardized photos before and 1 month after the end of the treatment. The criteria of success will be at least 75% of repigmentation.

Conditions

Interventions

TypeNameDescription
DEVICEGroup Laser = Arm AOpposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
DRUGBras B : The group controlpatient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids

Timeline

Start date
2010-03-01
Primary completion
2010-03-01
Completion
2011-03-01
First posted
2010-03-16
Last updated
2012-03-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01087216. Inclusion in this directory is not an endorsement.