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

Androgenic Alopecia Clinical Trial

Official title:

Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341363
• Other study ID #: 2000027404
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: May 2, 2022

Study information

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

Clinical Trial Summary

The intent of this study is to evaluate the efficacy of microneedling through use of a professional tattoo machine in hair regrowth in patients with androgenic alopecia (AGA) over up to 6 treatments (6 months).

Description:

Proposed is an open label trial of tattoo machine microneedling in ten patients with androgenic alopecia. Ten healthy male 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). Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symmetric hair loss from AGA
• Hamilton-Norwood IIIa, III, III vertex, IV, Iva, V with low density hair coverage over majority of alopecic areas
• No or minimal scalp hair regrowth on oral and/or topical minoxidil

Exclusion Criteria:

• Any male with hair loss for other reasons
• Unilateral or asymmetric hair loss
• Hamilton-Norwood I, II, IIa, Va, IV, VII x
• Patients without hair
• Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or 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
• Androgenic Alopecia

Intervention

Device:
• Tattoo machine
A SOL Nova Device (brand) 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	Total number of hairs in an area of 1 cm^2	6 months
Secondary	SALT Score	The Severity of Alopecia Tool measures percentage of scalp hair loss	6 months
Secondary	Hair Shaft Diameter	The diameter of the hair shaft as measured by trichoscopy	6 months
Secondary	Number of Follicular Units	Number of follicular units with one or more hair follicles over an area of 1cm^2	6 months
Secondary	Vellus Hairs	Number of vellus hairs over an area of 1 cm^2	6 months
Secondary	Terminal Hairs	Terminal hairs over an area of 1 cm^2	6 months