Androgenic AlopeciaNCT04341363
Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling
A study testing Tattoo machine in people with Androgenic Alopecia, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Tattoo machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 2 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Androgenic Alopecia
- Being tested
- Tattoo machine
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tattoo machineDevice
A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | Experimental | Participants with androgenic alopecia will receive microneedling with a tattoo machine. Receives: Device: Tattoo machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Area Hair Count
Total number of hairs in an area of 1 cm^2
Measured: 6 months
Secondary outcomes (5)
SALT Score
The Severity of Alopecia Tool measures percentage of scalp hair loss
Measured: 6 months
Hair Shaft Diameter
The diameter of the hair shaft as measured by trichoscopy
Measured: 6 months
Number of Follicular Units
Number of follicular units with one or more hair follicles over an area of 1cm^2
Measured: 6 months
Vellus Hairs
Number of vellus hairs over an area of 1 cm^2
Measured: 6 months
Terminal Hairs
Terminal hairs over an area of 1 cm^2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start9 Apr 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett King, MD, PhD, Principal investigator, Associate Professor of Dermatology, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341363
- Sponsor's protocol ID
- 2000027404
- Status last verified
- May 2023
- First submitted
- 6 Apr 2020
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
- ClinicalTrials.gov ID
- NCT04341363
- Acronym / sponsor ID
- 2000027404
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microneedling | Experimental | Device: Tattoo machineParticipants with androgenic alopecia will receive microneedling with a tattoo machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tattoo machineA SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth. | Device | Microneedling |
Primary outcome
Total Area Hair Count
Time frame: 6 months
Total number of hairs in an area of 1 cm^2
5 secondary outcomes
SALT Score
Time frame: 6 months
Hair Shaft Diameter
Time frame: 6 months
Number of Follicular Units
Time frame: 6 months
Vellus Hairs
Time frame: 6 months
Terminal Hairs
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett King, MD, PhD principal investigator
Associate Professor of Dermatology, Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tattoo machine in people with Androgenic Alopecia, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Area Hair Count (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.