Back to resultsFollicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tattoo machine (SOL Nova Device)
Sponsored by
About this trial
This is an interventional device feasibility trial for Alopecia Areata
Eligibility Criteria
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
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microneedling
Arm Description
Participants with Alopecia Areata will receive microneedling with a tattoo machine.
Outcomes
Primary Outcome Measures
Target area hair count (TAHC)
Total number of hairs in the area that undergoes microneedling
Secondary Outcome Measures
Hair phase
Number of catagen, anagen hairs
Vellus hairs
Number of vellus hairs in an area of 1cm^2
Terminal hairs
Number of terminal hairs in an area of 1cm^2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04338295
Brief Title
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
Official Title
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microneedling
Arm Type
Experimental
Arm Description
Participants with Alopecia Areata will receive microneedling with a tattoo machine.
Intervention Type
Device
Intervention Name(s)
Tattoo machine (SOL Nova Device)
Intervention Description
A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
Primary Outcome Measure Information:
Title
Target area hair count (TAHC)
Description
Total number of hairs in the area that undergoes microneedling
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hair phase
Description
Number of catagen, anagen hairs
Time Frame
6 months
Title
Vellus hairs
Description
Number of vellus hairs in an area of 1cm^2
Time Frame
6 months
Title
Terminal hairs
Description
Number of terminal hairs in an area of 1cm^2
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett King, MD, PhD
Organizational Affiliation
Associate Professor of Dermatology, Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
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