Face facial papules in frontal fibrosing alopecia: laser treatment using AviClear
Official title: Evaluating the Efficacy of the 1726nm Laser for the Treatment of Facial Papules in Frontal Fibrosing Alopecia (FFA)
Run by University of Miami · NCT07340671 · Data updated 2026-11-12
We are testing whether the Cutera 1726 nm laser can safely and effectively reduce facial papules in people with frontal fibrosing alopecia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | April 26, 2027 |
| Study ends | April 28, 2027 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07340671 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults of any gender with a clinical diagnosis of frontal fibrosing alopecia and facial papules, who can read/speak English or Spanish and consent to follow the treatment protocol.
✕Probably not a fit
Patients with no improvement in papules or who experience adverse effects from laser therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study uses the Cutera 1726 nm laser system (AviClear) to treat facial papules associated with frontal fibrosing alopecia. It is an interventional, non-randomized evaluation focusing on safety and potential benefit of the laser for this condition. Eligible adults with FFA and facial papules will receive laser treatment and will follow a defined pre- and post-treatment care plan, including photography for study documentation. The trial is sponsored by the University of Miami with collaboration from Cutera Inc., and is conducted at the University of Miami in Miami, Florida.
Why it matters
Potential benefit: If successful, participants may experience a reduction in facial papules and improvement in facial appearance.
How similar studies have gone: Other studies using similar laser approaches for facial lesions have shown variable safety and efficacy; this specific protocol is exploratory for FFA-related papules.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
Where it's running
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University of Miami
Miami, Florida, United States Recruiting
Study contacts
- Study coordinator: Maria V Muniz
- Email: mmuniz@med.miami.edu
- Phone: 305-689-2646
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Deucravacitinib for scarring hair loss (frontal fibrosing and central centrifugal alopecia)
This trial will test whether taking deucravacitinib once daily for 48 weeks helps adults with frontal fibrosing alopecia or central centrifugal cicatricial alopecia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.