NCT04342091

Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.

Detailed description

The investigators propose an open label trial of tattoo machine microneedling in ten patients with fibrosing alopecia (five patients with CCCA and five with FFA). Ten healthy female patients older than 18 years will undergo 6 microneedling sessions. Over the course of six months, subjects will undergo up to six treatment sessions (one session every 30 day). Photographs will be taken at each session. Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes. 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

• Fibrosing Alopecia
• Frontal Fibrosing Alopecia
• Central Centrifugal Cicatricial Alopecia

Interventions

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

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-04-08
• Completion: 2022-04-08
• First posted: 2020-04-10
• Last updated: 2023-04-13
• Results posted: 2023-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study