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

Phase 2

Terminated

• Conditions: Vitiligo
• Interventions: Biological: Placebo; Biological: Outer-Root-Sheath Melanocytes Suspension

• Registration Number: NCT01923142
• Lead Sponsor: Centro Studi Gised

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-15
• Study Start: 2014-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy
Outer-Root-Sheath Melanocytes Suspension	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

Primary Outcome Measures

Name	Time	Method
Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis	12 weeks

Secondary Outcome Measures

Name	Time	Method
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
Any repigmentation of the treated areas from baseline as assessed by image analysis	6 weeks, 12 weeks
Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale	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

Trial Locations

Locations (2)

Spedali Civili; 🇮🇹 Brescia, Italy

Papa Giovanni XXIII Hospital; 🇮🇹 Bergamo, Italy