Comparison of the Efficacy of Micro-holes vs. Laser-assisted Dermabrasion, for Repigmenting in Vitiligo Skin

NCT02660320 | Completed

• 1 other identifier: 15-PP-09
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo. A total of 10 patients with stable non-segmental vitiligo will be included in the ITT population. In each patient, three separate test areas will be selected in the same part of the body. One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension alone and the two others will receive the epidermal cell suspension in hyaluronic acid after pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his own control. Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week after cell grafting.

Conditions

Vitiligo - Macular Depigmentation

Outcome Measures

Primary Outcomes (1)

• Rate of repigmentation lesions

  Rate of repigmentation lesions at 3 months

  at 3 months

Secondary Outcomes (3)

• Global satisfaction expressed by the patient

  at 3 months

• EVA scale

  During the procedure

• -Contrast between treated and perilesional area (Nottingham scale)

  at 3 months

Study Arms (2)

Dermabrasion

ACTIVE COMPARATOR

Dermabrasion using dermaroller: The dermaroller is applied on the treated areas, this dermabrasion technique is based on micro holes performed using 540 micro needles (200µm depth) which should allow the penetration of the suspension cells or hyaluronic acid alone. Twelve passages will be performed on the treated area in order to achieve 60% of coverage.

Device: Dermabrasion

Laser

PLACEBO COMPARATOR

To prepare the graft recipient site, the upper layer of epidermis is removed by superficial dermabrasion using Erbium or CO2 ablative laser. The test area is ready to receive suspension cells when the dermis will appeared. The cells suspension will be applied on the wound.

Device: Laser placebo

Interventions

Dermabrasion DEVICE

Preparing the graft bed before epidermal cell suspension The epidermis can be removed using ablative CO2 or Erbium laser. We will assess the efficacy of using instead micro-needles to create micro-holes that will allow the melanocytes to reach the lower layers of the epidermis and thus repigment the lesional skin.

Dermabrasion

Laser placebo DEVICE

The epidermis can be removed using ablative CO2 or Erbium laser. We will assess the efficacy of using instead micro-needles to create micro-holes that will allow the melanocytes to reach the lower layers of the epidermis and thus repigment the lesional skin.

Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged over 18 years old with a diagnosis of non-segmental lesions that has been stable over three months
• The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.
• For each patient the lesions are located on the same area (either chest, back, legs or arms)
• The lesion area must be: 2cm2 \< lesion\<50cm2
• Treatment resistant areas (failure of at least one medical procedure topical tacrolimus or topical steroids for 6 months).
• Absence of infected lesion
• Lesions stable for at least one year

You may not qualify if:

• Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
• Indication against biopsies
• Patient with a history of melanoma
• Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C)
• History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
• Infected lesion
• Patient with concomitant photosensitizing treatment
• Age \<18 years
• Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent
• Pregnant,delivering or lactating patients. For the women childbearing potential, a urinary pregnancy test will be done and effective contraception will be expected.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

CHU de Nice

Nice, Alpes-Maritimes, 06200, France

Location

CHU de Bordeaux

Bordeaux, 33 000, France

Location

CH Creteil

Paris, Île-de-France Region, France

Location

MeSH Terms

Interventions

Dermabrasion

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Passeron Thierry, PhD

  Dermatology, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 21, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 31, 2022

Record last verified: 2018-01

Locations

FR (3)