Facial Papules in Frontal Fibrosing Alopecia (FFA)

Evaluating the Efficacy of the 1726nm Laser for the Treatment of Facial Papules in Frontal Fibrosing Alopecia (FFA)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Frontal Fibrosing Alopecia
• Intervention / Treatment: Device: Cutera® 1726 nm laser system

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria V Muniz; Phone Number: 305-689-2646; Email: mmuniz@med.miami.edu
• Study Contact Backup: Name: Leigh Nattkemper, PhD; Phone Number: 305-588-9734; Email: lxn202@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Contact: Ariel Eber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1726 nm Laser Treatment Group; Participants will be in this group for up to approximately 30 weeks and complete up to 5 visits	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.; Other Names: Cutera®; AviClear®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound	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.	Baseline periprocedural and through study completion (an average of 30 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lesion count measured by physical examination	Lesions will be counted manually during physical examination at each time point. Counts will be compared to baseline to assess treatment response	Baseline periprocedural and through study completion (an average of 30 weeks)
Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound	Using optical coherence tomography (OCT) and/or ultrasound to measure subsurface changes, including lesion depth and size. Measurements will be compared to baseline to evaluate treatment response.	Baseline, periprocedural, and through study completion (an average of 30 weeks)
Change in appearance of facial papules assessed by standardized global photography	Facial papule appearance will be documented using standardized global photographs at each time point. Images will be evaluated for visual changes compared to baseline.	Baseline, periprocedural and through study completion (an average of 30 weeks)
Change in Physician Global Assessment (PGA) score (9-point ordinal scale)	A board-certified physician will evaluate overall lesion severity using a standardized 9-point ordinal scale. Scores range from 0-8, with higher scores indicate greater severity. Scores at follow-up will be compared to baseline to assess treatment response.	Baseline and through study completion (an average of 30 weeks)
Blinded dermatologist evaluation	Before and after photos will be provided to three blinded dermatologists. Dermatologists will be asked to identify the correct before and after photos. Correct identification greater than or equal to 80% percent of the time is considered statistically significant.	After data collection is completed (an average of 30 weeks from baseline)

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Cutera Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 27, 2026
• Primary Completion (Estimated): April 26, 2027
• Study Completion (Estimated): April 28, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20250543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No