Alopecia AreataNCT04338295
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
A study testing Tattoo machine (SOL Nova Device) in people with Alopecia Areata, run by Yale University at 1 site in United States.
Trial summary
The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy. 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
- Alopecia Areata
- What is being tested?
- Tattoo machine (SOL Nova Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of AA
- SALT score ≥90%
- No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment
Who cannot join
- Known concomitant androgenetic or other form of alopecia (in addition to AA)
- 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
The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.
Read the detailed description
This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.
- Conditions
- Alopecia Areata
- Being tested
- Tattoo machine (SOL Nova Device)
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tattoo machine (SOL Nova Device)Device
A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | Experimental | Participants with Alopecia Areata will receive microneedling with a tattoo machine. Receives: Device: Tattoo machine (SOL Nova Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target area hair count (TAHC)
Total number of hairs in the area that undergoes microneedling
Measured: 6 months
Secondary outcomes (3)
Hair phase
Number of catagen, anagen hairs
Measured: 6 months
Vellus hairs
Number of vellus hairs in an area of 1cm^2
Measured: 6 months
Terminal hairs
Number of terminal hairs in an area of 1cm^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 posted8 Apr 2020
- Study start9 Apr 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT04338295
- Sponsor's protocol ID
- 2000027352
- Status last verified
- Dec 2022
- First submitted
- 3 Apr 2020
- Last updated
- 9 Dec 2022
- Results posted
- No
- 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 9 Dec 2022. 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
- NCT04338295
- Acronym / sponsor ID
- 2000027352
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.
Detailed description
This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microneedling | Experimental | Device: Tattoo machine (SOL Nova Device)Participants with Alopecia Areata 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)
- Diagnosis of AA
- SALT score ≥90%
- No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment
Key exclusion criteria (3 listed)
- Known concomitant androgenetic or other form of alopecia (in addition to AA)
- 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
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 machine (SOL Nova Device)A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth. | Device | Microneedling |
Primary outcome
Target area hair count (TAHC)
Time frame: 6 months
Total number of hairs in the area that undergoes microneedling
3 secondary outcomes
Hair phase
Time frame: 6 months
Vellus hairs
Time frame: 6 months
Terminal hairs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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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 (SOL Nova Device) in people with Alopecia Areata, 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 3 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 9 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Target area hair count (TAHC) (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 9 Dec 2022.