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

May 25, 2023 updated by: Yale University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Brett King, MD, PhD, Associate Professor of Dermatology, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

May 2, 2022

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000027404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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