NCT04338295

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DEVICE	Tattoo machine (SOL Nova Device)	A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2020-04-08
• Last updated: 2022-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study