Facial Papules in Frontal Fibrosing Alopecia (FFA)

NCT07340671 | Not Yet Recruiting FDA Device

• 1 other identifier: 20250543
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Frontal Fibrosing Alopecia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in lesion count measured by physical examination

  Baseline periprocedural and through study completion (an average of 30 weeks)

• Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound

  Baseline, periprocedural, and through study completion (an average of 30 weeks)

• Change in appearance of facial papules assessed by standardized global photography

  Baseline, periprocedural and through study completion (an average of 30 weeks)

• Change in Physician Global Assessment (PGA) score (9-point ordinal scale)

  Baseline and through study completion (an average of 30 weeks)

• Blinded dermatologist evaluation

  After data collection is completed (an average of 30 weeks from baseline)

Study Arms (1)

1726 nm Laser Treatment Group

EXPERIMENTAL

Participants will be in this group for up to approximately 30 weeks and complete up to 5 visits

Device: Cutera® 1726 nm laser system

Interventions

Cutera® 1726 nm laser system DEVICE

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.

Also known as: Cutera®, AviClear®

1726 nm Laser Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Cutera Inc.: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Central Study Contacts

Maria V Muniz

CONTACT

305-689-2646; mmuniz@med.miami.edu

Leigh Nattkemper, PhD

CONTACT

305-588-9734; lxn202@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 14, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): April 26, 2027
• Study Completion (Estimated): April 28, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)