Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
1 other identifier
interventional
6
1 country
1
Brief Summary
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
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
April 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2022
CompletedResults Posted
Study results publicly available
April 13, 2023
CompletedApril 13, 2023
March 1, 2023
12 months
April 6, 2020
March 21, 2023
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Total Area Hair Count (Frontal)
Total number of hairs over an area of 1cm\^2
6 months
Total Area Hair Count (Vertex)
Total number of hairs over an area of 1 cm\^2
6 months
Secondary Outcomes (8)
Hair Shaft Diameters (Frontal)
6 months
Hair Shaft Diameters (Vertex)
6 months
Number of Hair Follicles (Frontal)
6 months
Number of Hair Follicles (Vertex)
6 months
Vellus Hairs (Frontal)
6 months
- +3 more secondary outcomes
Study Arms (1)
Microneedling
EXPERIMENTALParticipants with fibrosing alopecia will receive microneedling with a tattoo machine.
Interventions
A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Eligibility Criteria
You may qualify if:
- Healthy Female
- Diagnosing Fibrosing alopecia
You may not qualify if:
- Any female with hair loss for other reasons
- Males
- Patients with cardiac conditions or renal insufficiency
- Pregnant patients
- Patients containing the following who would make poor candidates for microneedling, such as skin conditions, diabetes, 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
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
April 8, 2022
Study Completion
April 8, 2022
Last Updated
April 13, 2023
Results First Posted
April 13, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share