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

Frontal Fibrosing Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342091
• Other study ID #: 2000027405
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: March 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• SOL Nova Device
A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Area Hair Count (Frontal)	Total number of hairs over an area of 1cm^2	6 months
Primary	Total Area Hair Count (Vertex)	Total number of hairs over an area of 1 cm^2	6 months
Secondary	Hair Shaft Diameters (Frontal)	Hair shaft diameter measured per trichoscopy	6 months
Secondary	Hair Shaft Diameters (Vertex)	Hair shaft diameter measured per trichoscopy	6 months
Secondary	Number of Hair Follicles (Frontal)	Number of hair follicles counted per 1cm^2	6 months
Secondary	Number of Hair Follicles (Vertex)	Number of hair follicles per 1 cm^2	6 months
Secondary	Vellus Hairs (Frontal)	Number of vellus hairs per cm^2	6 months
Secondary	Vellus Hairs (Vertex)	Number of vellus hairs per cm^2	6 months
Secondary	Terminal Hairs (Frontal)	Number of terminal hairs over an area of 1 cm^2	6 months
Secondary	Terminal Hairs (Vertex)	Number of terminal hairs per area of 1 cm^2	6 months