A Phase 2/3 interventional study of Group Laser = Arm A and Bras B : The group control in Vitiligo, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-03-26.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2/3, Interventional, and Treatment
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.
298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 227 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
Device: Group Laser = Arm A
patient to accept habitual treatment of corticoid
Drug: Bras B : The group control
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
patient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids
Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy
Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy
Time frame: 4 months
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice