Hair Transplantation for Treatment of Vitiligo

NCT04858152 | Withdrawn

• 1 other identifier: H00022455
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (2)

• 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.

  evaluated 10 days post-procedure visit

• 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%)

  evaluated at 3 month follow up visit

Study Arms (1)

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

EXPERIMENTAL

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.

Procedure: Follicular Unit Extraction via punch biopsy

Interventions

Follicular Unit Extraction via punch biopsy PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mehdi Rashighi: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

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

Study Officials

• Mehdi Rashighi, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 26, 2021
• Study Start: August 1, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)