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

NCT01087216 | Completed Phase 2

• 2 other identifiers: 09-PP-082010-A00021-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group Laser = Arm As A

ACTIVE COMPARATOR

Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy

Device: Group Laser = Arm A

Bras B : the control group

PLACEBO COMPARATOR

patient to accept habitual treatment of corticoid

Drug: Bras B : The group control

Interventions

Group Laser = Arm A DEVICE

Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy

Group Laser = Arm As A

Bras B : The group control DRUG

patient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids

Bras B : the control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• PASSERON Ph Thierry, Md

  CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 26, 2012

Record last verified: 2010-03

Locations

FR (1)