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OpenTrials
Completed

NCT Number: NCT01087216

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Nice, Alpes-Maritimes, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Group Laser = Arm A

Device

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

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

Primary outcomes

  1. Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 16, 2010
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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