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

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

Study Overview

• Status: Completed
• Conditions: Fibrosing Alopecia; Frontal Fibrosing Alopecia; Central Centrifugal Cicatricial Alopecia
• Intervention / Treatment: Device: SOL Nova Device

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Brett King, MD, PhD, Associate Professor of Dermatology, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 2000027405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes