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

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Device: Group Laser = Arm A; Drug: Bras B : The group control

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Laser = Arm As A; Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy	Device: Group Laser = Arm A; Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
Placebo Comparator: Bras B : the control group; patient to accept habitual treatment of corticoid	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: PASSERON Ph Thierry, Md, CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (Estimate): March 16, 2010

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 09-PP-08; 2010-A00021-38 (Other Grant/Funding Number: AFSSAPS)