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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01087216
First received: March 15, 2010
Last updated: March 23, 2012
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Vitiligo
Device: Group Laser = Arm A
Drug: Bras B : The group control
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087216

Locations
France
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Nice, Alpes-Maritimes, France, 06001
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01087216     History of Changes
Other Study ID Numbers: 09-PP-08, 2010-A00021-38
Study First Received: March 15, 2010
Last Updated: March 23, 2012
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014