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

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

Detailed Description
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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.

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

Conditions
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Fibrosing Alopecia, Frontal Fibrosing Alopecia, Central Centrifugal Cicatricial Alopecia

Intervention / Treatment
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* Device: SOL Nova Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microneedling<br>Participants with fibrosing alopecia will receive microneedling with a tattoo machine. | Device: SOL Nova Device<br>* A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Area Hair Count (Frontal) | Total number of hairs over an area of 1cm^2 | 6 months | 
| Total Area Hair Count (Vertex) | Total number of hairs over an area of 1 cm^2 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Shaft Diameters (Frontal) | Hair shaft diameter measured per trichoscopy | 6 months | 
| Hair Shaft Diameters (Vertex) | Hair shaft diameter measured per trichoscopy | 6 months | 
| Number of Hair Follicles (Frontal) | Number of hair follicles counted per 1cm^2 | 6 months | 
| Number of Hair Follicles (Vertex) | Number of hair follicles per 1 cm^2 | 6 months | 
| Vellus Hairs (Frontal) | Number of vellus hairs per cm^2 | 6 months | 
| Vellus Hairs (Vertex) | Number of vellus hairs per cm^2 | 6 months | 
| Terminal Hairs (Frontal) | Number of terminal hairs over an area of 1 cm^2 | 6 months | 
| Terminal Hairs (Vertex) | Number of terminal hairs per area of 1 cm^2 | 6 months |