Melanocyte Transplantation for Patients With Stable Vitiligo.

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Spanish Clinical Research Network - CAIBER

Spanish Health Ministery

Information provided by (Responsible Party):

Clinica Universidad de Navarra, Universidad de Navarra

ClinicalTrials.gov Identifier:

NCT01701648

First received: October 3, 2012

Last updated: January 15, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 3, 2012
Last Updated Date	January 15, 2013
Start Date ^ICMJE	December 2010
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01701648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Melanocyte Transplantation for Patients With Stable Vitiligo.
Official Title ^ICMJE	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.
Brief Summary	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.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Stable Vitiligo
Intervention ^ICMJE	Other: Laser CO2 Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	30
Completion Date	June 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01701648
Other Study ID Numbers ^ICMJE	LEA/VIT, 2009-017757-36
Has Data Monitoring Committee	No
Responsible Party	Clinica Universidad de Navarra, Universidad de Navarra
Study Sponsor ^ICMJE	Clinica Universidad de Navarra, Universidad de Navarra
Collaborators ^ICMJE	Spanish Clinical Research Network - CAIBER Spanish Health Ministery
Investigators ^ICMJE	Not Provided
Information Provided By	Clinica Universidad de Navarra, Universidad de Navarra
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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