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

Yale University

Status: Completed

Conditions: Central Centrifugal Cicatricial Alopecia; Frontal Fibrosing Alopecia; Fibrosing Alopecia

Treatments: Device: SOL Nova Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04342091

2000027405

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Female
• Diagnosing Fibrosing alopecia

Exclusion criteria

• Any female with hair loss for other reasons
• Males
• Patients with cardiac conditions or renal insufficiency
• Pregnant patients
• Patients containing the following who would make poor candidates for microneedling, such as skin conditions, diabetes, history of keloid formation
• Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Microneedling

Experimental group

Description:

Participants with fibrosing alopecia will receive microneedling with a tattoo machine.

Treatment:

Device: SOL Nova Device