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
| Type | Name | Description |
|---|---|---|
| DEVICE | Group Laser = Arm A | Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy |
| DRUG | Bras B : The group control | patient 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.