Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
1 other identifier
interventional
8
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedStudy Start
First participant enrolled
April 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2022
CompletedResults Posted
Study results publicly available
June 18, 2023
CompletedJune 18, 2023
May 1, 2023
1.1 years
April 6, 2020
April 28, 2023
May 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Total Area Hair Count
Total number of hairs in an area of 1 cm\^2
6 months
Secondary Outcomes (5)
SALT Score
6 months
Hair Shaft Diameter
6 months
Number of Follicular Units
6 months
Vellus Hairs
6 months
Terminal Hairs
6 months
Study Arms (1)
Microneedling
EXPERIMENTALParticipants with androgenic alopecia will receive microneedling with a tattoo machine.
Interventions
A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brett King
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Brett King, MD, PhD
Associate Professor of Dermatology, Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2020
First Posted
April 10, 2020
Study Start
April 9, 2021
Primary Completion
May 2, 2022
Study Completion
May 2, 2022
Last Updated
June 18, 2023
Results First Posted
June 18, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share