Facial Papules in Frontal Fibrosing Alopecia (FFA)

University of Miami

Status

Not yet enrolling

Conditions

Frontal Fibrosing Alopecia

Treatments

Device: Cutera® 1726 nm laser system

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07340671

20250543

Details and patient eligibility

About

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).

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Suffering from diagnosed immunosuppression/immune deficiency disorders 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.