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

Vitiligo Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087216
• Other study ID #: 09-PP-08
• Secondary ID: 2010-A00021-38
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 15, 2010
• Last updated: March 23, 2012
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2010
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age between 18 at 85

• Not segmental Vitiligo of clinical diagnosis located on bony projections or of ends

• Two symmetrical plates of vitiligo of more than 4 cm ²

Exclusion Criteria:

• Pregnant women or breastfeeding.

• Vitiligo lesions on face and neck

• Personal history of skin cancer

• Photosensitize drugs

• Personal history of photodermatosis

• Personal history of keloids

• Concomitant treatment that could have an action on vitiligo (such as tacrolimus or pimecrolimus).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months	No