Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Group Laser = Arm A
Bras B : The group control
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo
Eligibility 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).
Sites / Locations
- CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group Laser = Arm As A
Bras B : the control group
Arm Description
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
patient to accept habitual treatment of corticoid
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01087216
First Posted
March 15, 2010
Last Updated
March 23, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01087216
Brief Title
Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Laser = Arm As A
Arm Type
Active Comparator
Arm Description
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
Arm Title
Bras B : the control group
Arm Type
Placebo Comparator
Arm Description
patient to accept habitual treatment of corticoid
Intervention Type
Device
Intervention Name(s)
Group Laser = Arm A
Intervention Description
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
Intervention Type
Drug
Intervention Name(s)
Bras B : The group control
Intervention Description
patient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids
Primary Outcome Measure Information:
Title
Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy
Description
Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PASSERON Ph Thierry, Md
Organizational Affiliation
CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
12. IPD Sharing Statement
Learn more about this trial
Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
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