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

Not Applicable

Completed

• Conditions: Fibrosing Alopecia; Central Centrifugal Cicatricial Alopecia; Frontal Fibrosing Alopecia
• Interventions: Device: SOL Nova Device

• Registration Number: NCT04342091
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-10
• Study Start: 2021-04-09
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Status Verified: 2023-03
• Results First Submitted: 2023-03-21
• Results First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Results First Posted: 2023-04-13
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

• Healthy Female
• Diagnosing Fibrosing alopecia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microneedling	SOL Nova Device	Participants with fibrosing alopecia will receive microneedling with a tattoo machine.

Primary Outcome Measures

Name	Time	Method
Total Area Hair Count (Vertex)	6 months	Total number of hairs over an area of 1 cm\^2
Total Area Hair Count (Frontal)	6 months	Total number of hairs over an area of 1cm\^2

Secondary Outcome Measures

Name	Time	Method
Hair Shaft Diameters (Vertex)	6 months	Hair shaft diameter measured per trichoscopy
Terminal Hairs (Frontal)	6 months	Number of terminal hairs over an area of 1 cm\^2
Number of Hair Follicles (Frontal)	6 months	Number of hair follicles counted per 1cm\^2
Vellus Hairs (Frontal)	6 months	Number of vellus hairs per cm\^2
Vellus Hairs (Vertex)	6 months	Number of vellus hairs per cm\^2
Number of Hair Follicles (Vertex)	6 months	Number of hair follicles per 1 cm\^2
Terminal Hairs (Vertex)	6 months	Number of terminal hairs per area of 1 cm\^2
Hair Shaft Diameters (Frontal)	6 months	Hair shaft diameter measured per trichoscopy

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States