NCT07340671 Facial Papules in Frontal Fibrosing Alopecia (FFA)
| NCT ID | NCT07340671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Frontal Fibrosing Alopecia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2027-04-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-04-28 with a primary completion date of 2027-04-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07340671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Frontal Fibrosing Alopecia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07340671 currently recruiting?
Yes, NCT07340671 is actively recruiting participants. Contact the research team at mmuniz@med.miami.edu for enrollment information.
Where is the NCT07340671 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07340671 clinical trial?
NCT07340671 is sponsored by University of Miami. The trial plans to enroll 10 participants.