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

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 3; Phase 2

Conditions: Vitiligo

Treatments: Drug: Bras B : The group control; Device: Group Laser = Arm A

Study type: Interventional

Funder types: Other

Identifiers

NCT01087216

2010-A00021-38 (Other Grant/Funding Number)

09-PP-08

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Group Laser = Arm As A

Active Comparator group

Description:

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

Treatment:

Device: Group Laser = Arm A

Bras B : the control group

Placebo Comparator group

Description:

patient to accept habitual treatment of corticoid

Treatment:

Drug: Bras B : The group control