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Hair Transplantation for Treatment of Vitiligo

Primary Purpose

Vitiligo

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Follicular Unit Extraction via punch biopsy

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults 18 years and older
Vitiligo patients already on treatment who demonstrate stable disease (have noted some repigmentation in hair bearing areas)
Willingness to participate in the study
Willingness to undergo biopsies of full-thickness skin tissue from areas without vitiligo and having them transplanted into areas with vitiligo
Informed consent agreement signed by the subject

Exclusion Criteria:

Adults unable to consent (adults lacking capacity)
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Unable to return for follow-up visits
Infection or other dermatologic condition different than vitiligo in the area to be treated
Personal or family history of keloid formation
Known allergies to injectable lidocaine or other topical anesthetics
Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks
Topical steroids at planned recipient site within the prior 1 week
Individuals who are unwilling to discontinue topical steroids at recipient site
Prescription or over-the-counter medication or cosmetics containing: retinoids, glycolic acid, salicylic acid, topical steroids at the site of treatment or oral corticosteroids, or any other remedies that might affect the healing process. Non-medicated moisturizers are allowed.
Co-existent inflammatory skin disease
Any other condition or laboratory value that would, in the professional opinion of the investigators, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Sites / Locations

University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm: Transplantation of hair follicles to non-hair bearing areas affected by vitiligo

Arm Description

Punch biopsies will be used to extract hair follicles from area on participant's body that is not affected by vitiligo and has hair growth. The follicles will then be transplanted into an area of the body affected by vitiligo that is hairless.

Outcomes

Primary Outcome Measures

Percentage of patients with successful engraftment of hair follicles to transplant site

Assessed by acceptance or rejection of graft into transplant site. Dermatologist will monitor for signs of rejection including infection, non-healing wounds, and necrosis of transplanted tissue and determine if transplant was successful (yes) or not (no), and the total percentage of successful cases will be calculated.

Percentage of repigmentation assessed by 4 point scale

Assessments of repigmentation will be performed by two dermatologists who will use photographs to determine percentage of repigmentation using the following scale: (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%)

Secondary Outcome Measures

Full Information

NCT ID

NCT04858152

First Posted

April 9, 2021

Last Updated

May 23, 2023

Sponsor

Mehdi Rashighi

1. Study Identification

Unique Protocol Identification Number

NCT04858152

Brief Title

Hair Transplantation for Treatment of Vitiligo

Official Title

Autologous Transplantation of Hair Follicles for the Treatment of Vitiligo on Glabrous Skin

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Logistic issues

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

August 15, 2022 (Anticipated)

Study Completion Date

August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mehdi Rashighi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

There are several surgical methods to treat vitiligo patches, and follicular unit extraction (FUE) is one among them. FUE, performed using punch biopsy extraction and hair follicle transplantation, has proven safe and effective in multiple studies for treatment of hair bearing (non-glabrous) skin. This technique has not yet been trialed on hairless areas (glabrous skin) affected by vitiligo, such as the lips, fingertips, knuckles, wrists, and feet, which tend to be resistant to standard treatments. We suspect this technique will be successful in patients who have responded well to other therapies in all areas except for non-hair bearing areas.

Detailed Description

Vitiligo is an autoimmune skin condition that can have a profound psychosocial impact on patients. Vitiligo is caused by an immune-mediated destruction of melanocytes, or the cells responsible for producing melanin, which gives the skin its pigment. There are safe and effective treatments for vitiligo, which should be selected based on disease subtype, the percentage of body surface area involved, patient preference, and the impact of the disease on a patient's quality of life. Treatment aims to stabilize depigmented lesions, reduce disease progression and stimulate repigmentation. The current therapies available include topical and systemic immunosuppressants, phototherapy and surgical techniques. The autologous transplantation of hair follicles has the ability to treat hairless areas by introducing follicular stem cells to an area of skin that would otherwise not respond to current treatment options. The potential to treat glabrous areas is of particular relevance for this technique, and the question proposed in this study is whether the same procedure of follicular hair transplant that has been previously safely and successfully used to treat segmental/stable vitiligo in hair bearing areas can applied to treat vitiligo in glabrous skin.

6. Conditions and Keywords

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

Vitiligo

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm: Transplantation of hair follicles to non-hair bearing areas affected by vitiligo

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Follicular Unit Extraction via punch biopsy

Intervention Description

Follicular unit extraction will be performed using standard 0.7mm - 1mm punch biopsies. The donor site, which will be selected as a vitiligo-free, hair-bearing area that is not visible per patient's preference, will be harvested via punch biopsies and transplanted to the recipient site, which will be the glabrous skin of the hands or feet.

Primary Outcome Measure Information:

Title

Percentage of patients with successful engraftment of hair follicles to transplant site

Description

Time Frame

evaluated 10 days post-procedure visit

Title

Percentage of repigmentation assessed by 4 point scale

Description

Time Frame

evaluated at 3 month follow up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults 18 years and older Vitiligo patients already on treatment who demonstrate stable disease (have noted some repigmentation in hair bearing areas) Willingness to participate in the study Willingness to undergo biopsies of full-thickness skin tissue from areas without vitiligo and having them transplanted into areas with vitiligo Informed consent agreement signed by the subject Exclusion Criteria: Adults unable to consent (adults lacking capacity) Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners Unable to return for follow-up visits Infection or other dermatologic condition different than vitiligo in the area to be treated Personal or family history of keloid formation Known allergies to injectable lidocaine or other topical anesthetics Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks Topical steroids at planned recipient site within the prior 1 week Individuals who are unwilling to discontinue topical steroids at recipient site Prescription or over-the-counter medication or cosmetics containing: retinoids, glycolic acid, salicylic acid, topical steroids at the site of treatment or oral corticosteroids, or any other remedies that might affect the healing process. Non-medicated moisturizers are allowed. Co-existent inflammatory skin disease Any other condition or laboratory value that would, in the professional opinion of the investigators, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehdi Rashighi, MD

Organizational Affiliation

University of Massachusetts, Worcester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Massachusetts Medical School

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Hair Transplantation for Treatment of Vitiligo

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