Efficacy of Autologous Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centro Studi Gised
Sponsor:
Collaborator:
ARIV Onlus
Information provided by (Responsible Party):
Centro Studi Gised
ClinicalTrials.gov Identifier:
NCT01923142
First received: August 9, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.


Condition Intervention Phase
Vitiligo
Biological: Outer-Root-Sheath Melanocytes Suspension
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

Resource links provided by NLM:


Further study details as provided by Centro Studi Gised:

Primary Outcome Measures:
  • Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Any repigmentation of the treated areas from baseline as assessed by image analysis [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Any repigmentation of other areas affected by vitiligo from baseline as assessed by physician according to an ordinal 6-points scale (evaluation of a possible systemic effect) [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Outer-Root-Sheath Melanocytes Suspension
This arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy
Biological: Outer-Root-Sheath Melanocytes Suspension
The treatment consists in depositing a suspension of autologous outer-root-sheath melanocytes, derived from patient's plucked hair follicles, and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).
Placebo Comparator: Placebo
This arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy
Biological: Placebo
The treatment consists in depositing a solution made of saline and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of symmetric lesions of vitiligo at the back of the hands with an extension >5cm²
  • Vitiligo lasting at least one year at the backs of both hands
  • Stable vitiligo, defined as vitiligo that presents no evident evolution (appearance of new lesions or increase in the extension of lesions already present) for at least 6 months
  • Suspension for at least two months prior to the enrollment date of any systemic drug for vitiligo such as immunosuppressive treatment (cyclosporine, systemic steroids) or psoralen + ultraviolet A therapy, phototherapy with ultraviolet B, and of any anticoagulant drug
  • Suspension of topical medications for at least 15 days prior to the enrollment date

Exclusion Criteria:

  • Presence of active vitiligo or Koebner phenomenon
  • Difference of more than 10% in the extension of symmetrical areas of vitiligo
  • Presence of systemic infections or infections localized to the tissues intended for transplantation
  • History of infections to the tissues intended for transplantation (herpes simplex, human papillomavirus infections, pityriasis versicolor, pityriasis alba)
  • Presence or history of malignancy
  • Chemotherapy or radiation therapy in progress
  • History of allergies or adverse reactions to local anesthetics
  • Presence of transmissible diseases (human immunodeficiency virus, hepatitis B and C, human T-lymphotropic virus type I and II, syphilis, cytomegalovirus, Creutzfeldt-Jacob, tuberculosis)
  • Women who are pregnant or intend to become pregnant during the study period (including breastfeeding women)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923142

Contacts
Contact: Simone Cazzaniga +39 035 2278 719 simone.cazzaniga@gised.it

Locations
Italy
Papa Giovanni XXIII Hospital Recruiting
Bergamo, Italy, 24127
Principal Investigator: Luigi Naldi, MD         
Spedali Civili Not yet recruiting
Brescia, Italy, 25123
Principal Investigator: Piergiacomo Calzavara Pinton, MD         
Sponsors and Collaborators
Centro Studi Gised
ARIV Onlus
Investigators
Principal Investigator: Luigi Naldi, MD Centro Studi Gised
  More Information

No publications provided

Responsible Party: Centro Studi Gised
ClinicalTrials.gov Identifier: NCT01923142     History of Changes
Other Study ID Numbers: VIT-FOL1
Study First Received: August 9, 2013
Last Updated: July 25, 2014
Health Authority: Italy: Ethics Committee
Italy: National Bioethics Committee

Keywords provided by Centro Studi Gised:
Vitiligo
Outer-Root-Sheath
Melanocytes
Hair Follicles

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014