Clinical trial NCT04858152: Hair Transplantation for Treatment of Vitiligo
Official title: Autologous Transplantation of Hair Follicles for the Treatment of Vitiligo on Glabrous Skin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of patients with successful engraftment of hair follicles to transplant site
timeFrame: evaluated 10 days post-procedure visit
measure: Percentage of repigmentation assessed by 4 point scale
timeFrame: evaluated at 3 month follow up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Mehdi Rashighi, MD
role: PRINCIPAL_INVESTIGATOR
References: