Facial Papules in Frontal Fibrosing Alopecia (FFA)

NCT ID: NCT07340671

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1726 nm Laser Treatment Group

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

Group Type: EXPERIMENTAL

Cutera® 1726 nm laser system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cutera®; AviClear®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ariel Eva Eber

Assistant Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Central Contacts

Maria V Muniz

Role: CONTACT

mmuniz@med.miami.edu

305-689-2646

Leigh Nattkemper, PhD

Role: CONTACT

lxn202@med.miami.edu

305-588-9734

Facility Contacts

Ariel Eber, MD

Role: primary

Other Identifiers

20250543

Identifier Type: -

Identifier Source: org_study_id