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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2022-05-02

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Androgenic Alopecia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microneedling

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

Group Type EXPERIMENTAL

Tattoo machine

Intervention Type DEVICE

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

Interventions

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Tattoo machine

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes