Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

• Sponsor: Yale University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04338295
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.7
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Device: Tattoo machine (SOL Nova Device)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
• Actual Study Start Date: Apr 9, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microneedling Participants with Alopecia Areata will receive microneedling with a tattoo machine.	Device: Tattoo machine (SOL Nova Device); A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.

Outcome Measures

Primary Outcome Measures

1. Target area hair count (TAHC) [6 months]

   Total number of hairs in the area that undergoes microneedling

Secondary Outcome Measures

1. Hair phase [6 months]

   Number of catagen, anagen hairs

2. Vellus hairs [6 months]

   Number of vellus hairs in an area of 1cm^2

3. Terminal hairs [6 months]

   Number of terminal hairs in an area of 1cm^2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Brett King, MD, PhD, Associate Professor of Dermatology, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04338295
• Other Study ID Numbers: 2000027352
• First Posted: Apr 8, 2020
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Alopecia; Alopecia Areata

Study Results

No Results Posted as of Jul 12, 2022