MedTrace Logo

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

NCT02660320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-08-31

No results posted yet for this study

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

Interventions

DEVICE

Dermabrasion

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.

DEVICE

Laser placebo

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Passeron Thierry, PhD · Dermatology, CHU de Nice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-10-31
Completion
2019-03-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02660320 on ClinicalTrials.gov