Fibrosing AlopeciaNCT04342091
Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
A study testing SOL Nova Device in people with Fibrosing Alopecia and Frontal Fibrosing Alopecia, run by Yale University at 1 site in United States.
Trial summary
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibrosing Alopecia, Frontal Fibrosing Alopecia, Central Centrifugal Cicatricial Alopecia
- What is being tested?
- SOL Nova Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 8 Apr 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Female
- Diagnosing Fibrosing alopecia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
Read the detailed description
The investigators propose an open label trial of tattoo machine microneedling in ten patients with fibrosing alopecia (five patients with CCCA and five with FFA). Ten healthy female 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). Photographs will be taken at each session. Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes. 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.
- Being tested
- SOL Nova Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOL Nova DeviceDevice
A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | Experimental | Participants with fibrosing alopecia will receive microneedling with a tattoo machine. Receives: Device: SOL Nova Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Area Hair Count (Frontal)
Total number of hairs over an area of 1cm^2
Measured: 6 months
Total Area Hair Count (Vertex)
Total number of hairs over an area of 1 cm^2
Measured: 6 months
Secondary outcomes (8)
Hair Shaft Diameters (Frontal)
Hair shaft diameter measured per trichoscopy
Measured: 6 months
Hair Shaft Diameters (Vertex)
Hair shaft diameter measured per trichoscopy
Measured: 6 months
Number of Hair Follicles (Frontal)
Number of hair follicles counted per 1cm^2
Measured: 6 months
Number of Hair Follicles (Vertex)
Number of hair follicles per 1 cm^2
Measured: 6 months
Vellus Hairs (Frontal)
Number of vellus hairs per cm^2
Measured: 6 months
Vellus Hairs (Vertex)
Number of vellus hairs per cm^2
Measured: 6 months
Terminal Hairs (Frontal)
Number of terminal hairs over an area of 1 cm^2
Measured: 6 months
Terminal Hairs (Vertex)
Number of terminal hairs per 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 completion8 Apr 2022
- Study completion8 Apr 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 Fibrosing 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
- 6 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
- NCT04342091
- Sponsor's protocol ID
- 2000027405
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2020
- Last updated
- 13 Apr 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
- ClinicalTrials.gov ID
- NCT04342091
- Acronym / sponsor ID
- 2000027405
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 13 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
Detailed description
The investigators propose an open label trial of tattoo machine microneedling in ten patients with fibrosing alopecia (five patients with CCCA and five with FFA). Ten healthy female 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). Photographs will be taken at each session. Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes. 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microneedling | Experimental | Device: SOL Nova DeviceParticipants with fibrosing alopecia will receive microneedling with a tattoo machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Female
- Diagnosing Fibrosing alopecia
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| SOL Nova DeviceA SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth. | Device | Microneedling |
Primary outcome
Total Area Hair Count (Frontal)
Time frame: 6 months
Total number of hairs over an area of 1cm^2
Total Area Hair Count (Vertex)
Time frame: 6 months
Total number of hairs over an area of 1 cm^2
8 secondary outcomes
Hair Shaft Diameters (Frontal)
Time frame: 6 months
Hair Shaft Diameters (Vertex)
Time frame: 6 months
Number of Hair Follicles (Frontal)
Time frame: 6 months
Number of Hair Follicles (Vertex)
Time frame: 6 months
Vellus Hairs (Frontal)
Time frame: 6 months
Vellus Hairs (Vertex)
Time frame: 6 months
Terminal Hairs (Frontal)
Time frame: 6 months
Terminal Hairs (Vertex)
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 13 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Fibrosing Alopecia
Not yet recruitingPhase 2
Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)
Frontal Fibrosing Alopecia
Recruiting
Facial Papules in Frontal Fibrosing Alopecia (FFA)
Frontal Fibrosing Alopecia
RecruitingPhase 2
Deucravacitinib in the Treatment of Cicatricial Alopecias
Central Centrifugal Cicatricial Alopecia, Frontal Fibrosing Alopecia
Not yet recruitingObservational study
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)
Frontal Fibrosing Alopecia, Cicatricial Alopecia
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 SOL Nova Device in people with Fibrosing Alopecia and Frontal Fibrosing 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 2 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 13 Apr 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 13 Apr 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 (Frontal) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 13 Apr 2023.