Frontal Fibrosing AlopeciaNCT07340671
Facial Papules in Frontal Fibrosing Alopecia (FFA)
A study testing Cutera® 1726 nm laser system in people with Frontal Fibrosing Alopecia, run by University of Miami at 1 site in United States.
Trial summary
The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of facial papules in frontal fibrosing alopecia (FFA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontal Fibrosing Alopecia
- What is being tested?
- Cutera® 1726 nm laser system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2026to 28 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or Male
- Fitzpatrick Skin Types I-VI
- At least 18 years of age
- Has clinically diagnosed FFA with facial papules.
- Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
- Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
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- No contraindication to laser therapy.
- Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study.
- Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.
Who cannot join
- Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
- Prior treatment to the target area within 3 months of study participating including chemical peel, dermabrassion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic therapy, or acne surgery.
- Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
- Systemic use of retinoid, such as isotretinoin, within 3 months of study participation.
- Still healing from another treatment in the target area according to investigator's discretion.
- History of malignant tumors in the target area.
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- Pregnant and/or breastfeeding or planning to become pregnant during the study.
- History of diagnosed immunosuppression/immune deficiency or currently using immunosuppressive medications.
- History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the target area, unless treatment is conducted following a prophylactic regimen.
- History of radiation to the target area, currently undergoing treatment for skin cancer in the target area, or undergoing systemic chemotherapy for the treatment of cancer.
- History of diagnosed pigmentary disorders (including vitiligo) in the target area.
- Excessively tanned in the treatment area or unable/unlikely to refrain from tanning in the target area during the study.
- History of keloids or hypertrophic scarring.
- Prisoners
- As per the Investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study, might interfere with patient's participation in the full study protocol, or might interfere with the diagnosis or assessment of facial papules.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Ariel Eber, MD
About this study
Official title: Evaluating the Efficacy of the 1726nm Laser for the Treatment of Facial Papules in Frontal Fibrosing Alopecia (FFA)
The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of facial papules in frontal fibrosing alopecia (FFA).
- Conditions
- Frontal Fibrosing Alopecia
- Being tested
- Cutera® 1726 nm laser system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutera® 1726 nm laser systemDevice
Also called Cutera®, AviClear®
Participants will receive 3 laser treatments at 4 (±1) week intervals and will be followed at approximately at 12 (± 2) weeks post treatment completion onsite.
| Study group | Role | What they receive |
|---|---|---|
| 1726 nm Laser Treatment Group | Experimental | Participants will be in this group for up to approximately 30 weeks and complete up to 5 visits Receives: Device: Cutera® 1726 nm laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound
Lesion size will be assessed using dermatoscope and ultrasound imaging. Measurements will be recorded in millimeters (mm) and compared to baseline values to evaluate treatment response.
Measured: Baseline periprocedural and through study completion (an average of 30 weeks)
Secondary outcomes (5)
Change in lesion count measured by physical examination
Lesions will be counted manually during physical examination at each time point. Counts will be compared to baseline to assess treatment response
Measured: Baseline periprocedural and through study completion (an average of 30 weeks)
Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound
Using optical coherence tomography (OCT) and/or ultrasound to measure subsurface changes, including lesion depth and size. Measurements will be compared to baseline to evaluate treatment response.
Measured: Baseline, periprocedural, and through study completion (an average of 30 weeks)
Change in appearance of facial papules assessed by standardized global photography
Facial papule appearance will be documented using standardized global photographs at each time point. Images will be evaluated for visual changes compared to baseline.
Measured: Baseline, periprocedural and through study completion (an average of 30 weeks)
Change in Physician Global Assessment (PGA) score (9-point ordinal scale)
A board-certified physician will evaluate overall lesion severity using a standardized 9-point ordinal scale. Scores range from 0-8, with higher scores indicate greater severity. Scores at follow-up will be compared to baseline to assess treatment response.
Measured: Baseline and through study completion (an average of 30 weeks)
Blinded dermatologist evaluation
Before and after photos will be provided to three blinded dermatologists. Dermatologists will be asked to identify the correct before and after photos. Correct identification greater than or equal to 80% percent of the time is considered statistically significant.
Measured: After data collection is completed (an average of 30 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start28 Apr 2026
- Primary completion26 Apr 2027 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontal Fibrosing AlopeciaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Cutera Inc.
- Responsible party
- Principal investigator, Ariel Eva Eber, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340671
- Sponsor's protocol ID
- 20250543
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of the 1726nm Laser for the Treatment of Facial Papules in Frontal Fibrosing Alopecia (FFA)
- ClinicalTrials.gov ID
- NCT07340671
- Acronym / sponsor ID
- 20250543
- Conditions
- Frontal Fibrosing Alopecia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Cutera Inc.
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 26 Apr 2027 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 14 Jan 2026 (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 objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of facial papules in frontal fibrosing alopecia (FFA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1726 nm Laser Treatment Group | Experimental | Device: Cutera® 1726 nm laser systemParticipants will be in this group for up to approximately 30 weeks and complete up to 5 visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or Male
- Fitzpatrick Skin Types I-VI
- At least 18 years of age
- Has clinically diagnosed FFA with facial papules.
- Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
Key exclusion criteria (17 listed)
- Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
- Prior treatment to the target area within 3 months of study participating including chemical peel, dermabrassion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic therapy, or acne surgery.
- Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
- Systemic use of retinoid, such as isotretinoin, within 3 months of study participation.
- Still healing from another treatment in the target area according to investigator's discretion.
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 |
|---|---|---|
| Cutera® 1726 nm laser systemAlso: Cutera®, AviClear®Participants will receive 3 laser treatments at 4 (±1) week intervals and will be followed at approximately at 12 (± 2) weeks post treatment completion onsite. | Device | 1726 nm Laser Treatment Group |
Primary outcome
Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound
Time frame: Baseline periprocedural and through study completion (an average of 30 weeks)
Lesion size will be assessed using dermatoscope and ultrasound imaging. Measurements will be recorded in millimeters (mm) and compared to baseline values to evaluate treatment response.
5 secondary outcomes
Change in lesion count measured by physical examination
Time frame: Baseline periprocedural and through study completion (an average of 30 weeks)
Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound
Time frame: Baseline, periprocedural, and through study completion (an average of 30 weeks)
Change in appearance of facial papules assessed by standardized global photography
Time frame: Baseline, periprocedural and through study completion (an average of 30 weeks)
Change in Physician Global Assessment (PGA) score (9-point ordinal scale)
Time frame: Baseline and through study completion (an average of 30 weeks)
Blinded dermatologist evaluation
Time frame: After data collection is completed (an average of 30 weeks from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutera® 1726 nm laser system in people with Frontal Fibrosing Alopecia, run by University of Miami 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 10 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria V Muniz (305-689-2646, mmuniz@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound (time frame: Baseline periprocedural and through study completion (an average of 30 weeks)). 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 24 Jul 2026.