Facial Papules in Frontal Fibrosing Alopecia (FFA)
United States10 participantsStarted 2026-04-27
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 participat…
What they're measuring
1
Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound
Timeframe: Baseline periprocedural and through study completion (an average of 30 weeks)