NCT07340671 · University of Miami
Facial Papules in Frontal Fibrosing Alopecia (FFA)
What this study is about
The objective is to evaluate the safety and effectiveness of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of facial papules in frontal fibrosing alopecia (FFA).
View original scientific description
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).
Interventions
DEVICE
Cutera® 1726 nm laser system
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
- Miami, Florida
Collaborators
Cutera Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations