Trial record 17 of 53 for:    "vitiligo"

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

This study is currently recruiting participants.
Verified January 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: January 15, 2014
Last verified: January 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 can lead to a significant skin repigmentation. To preliminarily assess the effect of the proposed treatment, a pilot within-subject controlled study involving symmetric lesions 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: December 2014
Estimated Primary Completion Date: September 2014 (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
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 dermal needling.
Placebo Comparator: Placebo
This arm includes all patients sides (left or right) treated with placebo
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 dermal needling.

  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
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: January 15, 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 April 15, 2014