Melanocyte Transplantation for Patients With Stable Vitiligo.

This study has been completed.
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01701648
First received: October 3, 2012
Last updated: October 11, 2013
Last verified: September 2013

October 3, 2012
October 11, 2013
December 2010
January 2013   (final data collection date for primary outcome measure)
Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01701648 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Melanocyte Transplantation for Patients With Stable Vitiligo.
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Stable Vitiligo
Other: Laser CO2
Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
Active Comparator: 1
Intervention: Other: Laser CO2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion criteria

  • Patients must voluntarily provide informed consent before any of the tests included in the trial which do not form part of standard treatment can be performed.
  • Mentally stable patients, suffering from piebaldism, vitiligo of metameric distribution, focal or generalized vitiligo which has remained stable for at least one year without de-pigmentation or spontaneous re-pigmentation after standard medical treatment.
  • A minimum hypopigmented area to treat of 100 cm2 (at least 30 cm2 for each of the therapeutic options).
  • For women of child-bearing age, a negative pregnancy test.

Exclusion criteria:

  • Women who are pregnant or breast-feeding.
  • Positive results in any of the blood tests given
  • Concomitant serious illness.
  • Patients who have received any agent currently the focus of research in the 30 days prior to their inclusion.
  • Patients currently participating in another clinical trial or receiving any other agent currently the focus of research.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01701648
LEA/VIT, 2009-017757-36
No
Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Spanish Clinical Research Network - CAIBER
Not Provided
Clinica Universidad de Navarra, Universidad de Navarra
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP