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

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: Alopecia Areata
• Intervention / Treatment: Device: Tattoo machine (SOL Nova Device)

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

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target area hair count (TAHC)	Total number of hairs in the area that undergoes microneedling	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair phase	Number of catagen, anagen hairs	6 months
Vellus hairs	Number of vellus hairs in an area of 1cm^2	6 months
Terminal hairs	Number of terminal hairs in an area of 1cm^2	6 months

Collaborators and Investigators

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

Study record dates

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: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• 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