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

Primary Purpose

Vitiligo

Status

Terminated

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Outer-Root-Sheath Melanocytes Suspension

Placebo

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Outer-Root-Sheath, Melanocytes, Hair Follicles

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Papa Giovanni XXIII Hospital
Spedali Civili

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Outer-Root-Sheath Melanocytes Suspension

Placebo

Arm Description

This arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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)

Full Information

NCT ID

NCT01923142

First Posted

August 9, 2013

Last Updated

January 26, 2016

Sponsor

Centro Studi Gised

Collaborators

ARIV Onlus

1. Study Identification

Unique Protocol Identification Number

NCT01923142

Brief Title

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

Official Title

Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Study Start Date

January 2014 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centro Studi Gised

Collaborators

ARIV Onlus

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Outer-Root-Sheath Melanocytes Suspension

Arm Type

Experimental

Arm Description

This arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Outer-Root-Sheath Melanocytes Suspension

Intervention Description

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).

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Time Frame

6 weeks, 12 weeks

Title

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

Time Frame

6 weeks, 12 weeks

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luigi Naldi, MD

Organizational Affiliation

Centro Studi Gised

Official's Role

Principal Investigator

Facility Information:

Facility Name

Papa Giovanni XXIII Hospital

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Spedali Civili

City

Brescia

ZIP/Postal Code

25123

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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