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

Not Applicable

Completed

• Conditions: Androgenic Alopecia
• Interventions: Device: Tattoo machine

• Registration Number: NCT04341363
• Lead Sponsor: Yale University

Brief 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).

Detailed 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.

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: 2022-05-02
• Study Completion: 2022-05-02
• Results First Submitted: 2023-04-28
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Results First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microneedling	Tattoo machine	Participants with androgenic alopecia will receive microneedling with a tattoo machine.

Primary Outcome Measures

Name	Time	Method
Total Area Hair Count	6 months	Total number of hairs in an area of 1 cm\^2

Secondary Outcome Measures

Name	Time	Method
Hair Shaft Diameter	6 months	The diameter of the hair shaft as measured by trichoscopy
Vellus Hairs	6 months	Number of vellus hairs over an area of 1 cm\^2
Terminal Hairs	6 months	Terminal hairs over an area of 1 cm\^2
SALT Score	6 months	The Severity of Alopecia Tool measures percentage of scalp hair loss
Number of Follicular Units	6 months	Number of follicular units with one or more hair follicles over an area of 1cm\^2

Trial Locations

Locations (1)

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