Melanocyte Transplantation for Patients With Stable Vitiligo.

NCT01701648 | Completed Phase 1

• 2 other identifiers: LEA/VIT2009-017757-36
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Vitiligo

Keywords

Vitiligo, amniotic membrane, malanocytes, C02 laser.

Outcome Measures

Primary Outcomes (1)

• Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo

  six months

Study Arms (1)

1

ACTIVE COMPARATOR

Other: Laser CO2

Interventions

Laser CO2 OTHER

Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant or breast-feeding.
• Positive results in any of the blood tests given
• Concomitant serious illness.
• Patients currently participating in another clinical trial or receiving any other agent currently the focus of research.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (1)

University Clinic of Navarre

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• Redondo P, Gimenez de Azcarate A, Nunez-Cordoba JM, Andreu EJ, Garcia-Guzman M, Aguado L, Prosper F. Efficacy of Autologous Melanocyte Transplantation on Amniotic Membrane in Patients With Stable Leukoderma: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):897-9. doi: 10.1001/jamadermatol.2015.0299. No abstract available.

  PMID: 25902042 DERIVED

MeSH Terms

Conditions

Vitiligo

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: December 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-09

Locations

ES (1)