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RecruitingNCT07340671Updated Jul 24, 2026

Facial Papules in Frontal Fibrosing Alopecia (FFA)

An interventional study of Cutera® 1726 nm laser system in Frontal Fibrosing Alopecia, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Frontal Fibrosing Alopecia
03

In context

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study 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

    Device: Cutera® 1726 nm laser system

Interventions

  • DeviceCutera® 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.

    Also known as: Cutera®, AviClear®

06

What researchers measure

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.

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

Secondary outcomes

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

07

Study locations

1 of 1 sites recruiting
  • University of Miami
    Miami, Florida 33136, United States
    • Ariel Eber, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07340671
Lead sponsor
University of Miami
Collaborators
Cutera Inc.
Responsible party
Ariel Eva Eber (Assistant Professor of Clinical, University of Miami) — Principal investigator
First posted
Jan 14, 2026
Start date
Apr 28, 2026
Primary completion
Apr 26, 2027 (estimated)
Completion
Apr 28, 2027 (estimated)
Last update
Jul 24, 2026

Study contacts

Maria V Muniz
Contact
mmuniz@med.miami.edu
305-689-2646
Leigh Nattkemper, PhD
Contact
lxn202@med.miami.edu
305-588-9734

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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