Stable Vitiligo Clinical Trial
Official title:
Phase I-II, Randomized, Intraindividually Placebo Controlled Clinical Trial, to Evaluate the Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo.
Vitiligo is an acquired skin disease that significantly impacts the quality of life of
patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but
the results are variable.
This single center, single blind clinical trial comparing another treatment and also no
treatment was designed to assess the efficacy of autologous monocyte transplantation in
monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo.
Patients will receive the two interventions, melanocyte suspension and monolayer on amniotic
membrane and will provide an untreated area as a control.
Main Objective:
The main objective is to assess the efficacy of autologous transplantation of monocytes in
monolayers grown on a biological substrate of amniotic membrane in the treatment of stable
vitiligo. Using a system of digital imaging analysis the percentage of re-pigmentation
obtained will be studied after 3, 6 and 9 months of treatment.
Secondary Objectives:
To demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of
each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with
melanocytes in monolayers.
To assess how rapidly epithelialization occurs and the cosmetic result in the short and long
term of the areas treated with each of the techniques.
To assess if de-epidermization with CO2 laser may be by itself a stimulus for the reservoir
of melanocytes in the adjacent epidermis or hair follicles or if the re-pigmentation
obtained with this procedure is merely postinflammatory as a result of trauma to the
epidermis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03535051 -
Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo
|
N/A |