Health TrialsbyHealthPanel

Facial Papules in Frontal Fibrosing Alopecia (FFA)

ConditionFrontal Fibrosing Alopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or Male

Fitzpatrick Skin Types I-VI

At least 18 years of age

Has clinically diagnosed FFA with facial papules.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: 1726 nm Laser Treatment GroupExperimental treatment 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Cutera Inc.

Collaborator

Source ClinicalTrials.gov
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