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

NCT01923142 | Terminated Phase 2

• 1 other identifier: VIT-FOL1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vitiligo

Keywords

Vitiligo; Outer-Root-Sheath; Melanocytes; Hair Follicles

Outcome Measures

Primary Outcomes (1)

• Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis

  12 weeks

Secondary Outcomes (5)

• Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale

  6 weeks, 12 weeks

• Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale

  6 weeks, 12 weeks

• Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale

  6 weeks, 12 weeks

• Any repigmentation of the treated areas from baseline as assessed by image analysis

  6 weeks, 12 weeks

• 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)

  6 weeks, 12 weeks

Study Arms (2)

Outer-Root-Sheath Melanocytes Suspension

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

This arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy

Biological: Placebo

Interventions

Outer-Root-Sheath Melanocytes Suspension BIOLOGICAL

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).

Outer-Root-Sheath Melanocytes Suspension

Placebo BIOLOGICAL

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).

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centro Studi Gised: lead
• ARIV Onlus: collaborator

Study Sites (2)

Papa Giovanni XXIII Hospital

Bergamo, 24127, Italy

Location

Spedali Civili

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

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

Study Officials

• Luigi Naldi, MD

  Centro Studi Gised

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 15, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

IT (2)