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

Study Overview
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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).

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.

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

Conditions
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Androgenic Alopecia

Intervention / Treatment
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* Device: Tattoo machine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microneedling<br>Participants with androgenic alopecia will receive microneedling with a tattoo machine. | Device: Tattoo machine<br>* A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Area Hair Count | Total number of hairs in an area of 1 cm^2 | 6 months | 

Secondary Outcome Measures

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