VitiligoNCT04858152
Hair Transplantation for Treatment of Vitiligo
A study testing Follicular Unit Extraction via punch biopsy in people with Vitiligo, run by Mehdi Rashighi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Follicular Unit Extraction via punch biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Autologous Transplantation of Hair Follicles for the Treatment of Vitiligo on Glabrous Skin
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Follicular Unit Extraction via punch biopsy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicular Unit Extraction via punch biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Follicular Unit Extraction via punch biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%)
Measured: evaluated at 3 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Aug 2021
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Aug 2023 (estimated)
Why it stopped: Logistic issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehdi Rashighi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehdi Rashighi, University of Massachusetts, Worcester
- Investigators
- Mehdi Rashighi, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858152
- Sponsor's protocol ID
- H00022455
- Status last verified
- May 2023
- First submitted
- 9 Apr 2021
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Hair Follicles for the Treatment of Vitiligo on Glabrous Skin
- ClinicalTrials.gov ID
- NCT04858152
- Acronym / sponsor ID
- H00022455
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistic issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mehdi RashighiUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Transplantation of hair follicles to non-hair bearing areas affected by vitiligo | Experimental | Procedure: Follicular Unit Extraction via punch biopsyPunch 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follicular Unit Extraction via punch biopsyFollicular 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. | Procedure or surgery | Experimental Arm: Transplantation of hair follicles to non-hair bearing areas affected by vitiligo |
Primary outcome
Percentage of patients with successful engraftment of hair follicles to transplant site
Time frame: evaluated 10 days post-procedure visit
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
Time frame: evaluated at 3 month follow up visit
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%)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi Rashighi, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follicular Unit Extraction via punch biopsy in people with Vitiligo, run by Mehdi Rashighi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with successful engraftment of hair follicles to transplant site (time frame: evaluated 10 days post-procedure visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.