- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338295
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
December 7, 2022 updated by: Yale University
The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment.
Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled.
Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months.
Procedures and visits are not standard of care but conducted for research.
Each visit will last about an hour.
Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit.
The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment.
During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment.
Remaining 10 minutes on visits 2 and 8 will be used for biopsy.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Diagnosis of AA
- SALT score ≥90%
- No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment
Exclusion Criteria:
- Known concomitant androgenetic or other form of alopecia (in addition to AA)
- Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation
- Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Microneedling
Participants with Alopecia Areata will receive microneedling with a tattoo machine.
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A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target area hair count (TAHC)
Time Frame: 6 months
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Total number of hairs in the area that undergoes microneedling
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hair phase
Time Frame: 6 months
|
Number of catagen, anagen hairs
|
6 months
|
Vellus hairs
Time Frame: 6 months
|
Number of vellus hairs in an area of 1cm^2
|
6 months
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Terminal hairs
Time Frame: 6 months
|
Number of terminal hairs in an area of 1cm^2
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brett King, MD, PhD, Associate Professor of Dermatology, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2021
Primary Completion (Actual)
May 16, 2022
Study Completion (Actual)
May 16, 2022
Study Registration Dates
First Submitted
April 3, 2020
First Submitted That Met QC Criteria
April 7, 2020
First Posted (Actual)
April 8, 2020
Study Record Updates
Last Update Posted (Estimate)
December 9, 2022
Last Update Submitted That Met QC Criteria
December 7, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000027352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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