Recruiting

AviClear

Sponsor:

University of Miami

Code:

NCT07340671

Conditions

Frontal Fibrosing Alopecia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cutera® 1726 nm laser system

Study Details

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 ID

NCT07340671

Start date

Apr 28, 2026

Status verified date

Apr, 2026

Completion date

Apr 28, 2027

Anticipated

Primary completion date

Apr 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1726 nm Laser Treatment Group

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

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.

Primary outcome measure

  • Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound [ Time Frame: Baseline periprocedural and through study completion (an average of 30 weeks) ]

Central Contacts and Locations

Central contacts

Maria V Muniz

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

Leigh Nattkemper, PhD

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

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

More Information

Sponsor

University of Miami

Last update posted

Jul 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-24.