Back to resultsFollicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling
Primary Purpose
Androgenic Alopecia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tattoo machine
Sponsored by
About this trial
This is an interventional treatment trial for Androgenic Alopecia
Eligibility Criteria
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
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microneedling
Arm Description
Participants with androgenic alopecia will receive microneedling with a tattoo machine.
Outcomes
Primary Outcome Measures
Total Area Hair Count
Total number of hairs in an area of 1 cm^2
Secondary Outcome Measures
SALT Score
The Severity of Alopecia Tool measures percentage of scalp hair loss
Hair Shaft Diameter
The diameter of the hair shaft as measured by trichoscopy
Number of Follicular Units
Number of follicular units with one or more hair follicles over an area of 1cm^2
Vellus Hairs
Number of vellus hairs over an area of 1 cm^2
Terminal Hairs
Terminal hairs over an area of 1 cm^2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04341363
Brief Title
Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling
Official Title
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
May 2, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microneedling
Arm Type
Experimental
Arm Description
Participants with androgenic alopecia will receive microneedling with a tattoo machine.
Intervention Type
Device
Intervention Name(s)
Tattoo machine
Intervention Description
A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
Primary Outcome Measure Information:
Title
Total Area Hair Count
Description
Total number of hairs in an area of 1 cm^2
Time Frame
6 months
Secondary Outcome Measure Information:
Title
SALT Score
Description
The Severity of Alopecia Tool measures percentage of scalp hair loss
Time Frame
6 months
Title
Hair Shaft Diameter
Description
The diameter of the hair shaft as measured by trichoscopy
Time Frame
6 months
Title
Number of Follicular Units
Description
Number of follicular units with one or more hair follicles over an area of 1cm^2
Time Frame
6 months
Title
Vellus Hairs
Description
Number of vellus hairs over an area of 1 cm^2
Time Frame
6 months
Title
Terminal Hairs
Description
Terminal hairs over an area of 1 cm^2
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett King, MD, PhD
Organizational Affiliation
Associate Professor of Dermatology, Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling
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