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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

March 15, 2010
March 23, 2012
March 2010
March 2010   (final data collection date for primary outcome measure)
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
Lesions that will received the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy [ Time Frame: visit of pre-inclusion; visit of inclusion and the beginning of application of creams (V1); three months of treatment and valuation 1 month after the stopping of treatments ] [ Designated as safety issue: No ]
Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy
Complete list of historical versions of study NCT01087216 on ClinicalTrials.gov Archive Site
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Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
Not Provided

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Vitiligo
  • 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
  • Active Comparator: Group Laser = Arm As A
    Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
    Intervention: Device: Group Laser = Arm A
  • Placebo Comparator: Bras B : the control group
    patient to accept habitual treatment of corticoid
    Intervention: Drug: Bras B : The group control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2011
March 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01087216
09-PP-08, 2010-A00021-38
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
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
Centre Hospitalier Universitaire de Nice
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP