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

NCT ID: NCT04342091

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2022-04-08

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.

Conditions

Fibrosing Alopecia; Frontal Fibrosing Alopecia; Central Centrifugal Cicatricial Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microneedling

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

Group Type: EXPERIMENTAL

SOL Nova Device

Intervention Type: DEVICE

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

Interventions

SOL Nova Device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett King, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Dermatology, Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000027405

Identifier Type: -

Identifier Source: org_study_id