Cutera Laser System for Hair Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new laser treatment for individuals with frontal fibrosing alopecia (FFA), a condition causing hair loss and facial papules (small bumps). Researchers aim to evaluate the safety and effectiveness of the Cutera 1726 nm laser system in treating these symptoms. The trial is open to adults diagnosed with FFA who have facial papules. Participants should be willing to follow a treatment schedule and refrain from other skin treatments during the study. As an unphased trial, this study allows participants to contribute to pioneering research that could lead to new treatment options for FFA.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot use medications that increase sensitivity to light or systemic retinoids like isotretinoin within 3 months of starting the study.
What prior data suggests that the Cutera 1726 nm laser system is safe for treating facial papules in frontal fibrosing alopecia?
Research has shown that the Cutera 1726 nm laser system, known as AviClear, received FDA approval for treating acne, confirming its safety in people. AviClear uses a specific type of light to target and reduce the activity of oil-producing glands in the skin.
No specific safety information exists for using this laser to treat facial bumps in frontal fibrosing alopecia (FFA). However, its approval for acne suggests potential safety. It's important to remember that while the laser is safe for acne, different skin conditions might respond differently. Participants should consider this when deciding to join the trial.12345Why are researchers excited about this trial?
The Cutera® 1726 nm laser system is unique because it uses a specific wavelength of light to target hair follicles, which could promote hair growth in a non-invasive way. Unlike traditional treatments for hair loss, such as finasteride or minoxidil, which rely on medications to stimulate hair growth, this laser treatment harnesses light energy to potentially achieve similar results without the need for daily application or systemic side effects. Researchers are excited about this treatment because it offers a novel approach that could be more convenient and potentially safer for those looking to address hair thinning or loss.
What evidence suggests that the Cutera 1726 nm laser system is effective for treating facial papules in frontal fibrosing alopecia?
Research shows that the Cutera 1726 nm laser system, known as AviClear, may help treat facial bumps in frontal fibrosing alopecia (FFA). In studies, the percentage of people with clear or almost clear skin increased over time: from 0% at the start to 9% at 4 weeks, 36% at 12 weeks, and 41.8% at 26 weeks. This laser heats the oil in skin glands, causing controlled damage that helps reduce symptoms. Clinical trials also suggest that breakouts become shorter, less severe, and less frequent after treatment. Overall, early evidence supports its potential effectiveness in managing FFA. Participants in this trial will receive the 1726 nm Laser Treatment to further evaluate its effectiveness.12356
Are You a Good Fit for This Trial?
This trial is for adults with diagnosed frontal fibrosing alopecia (FFA) featuring facial papules. Participants must have no issues with laser therapy, be able to follow the study's schedule and care instructions, and consent to use only approved skincare products during the trial. They should also agree to photo documentation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the 1726 nm laser treatment for facial papules in frontal fibrosing alopecia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cutera® 1726 nm laser system
Trial Overview
The Cutera 1726 nm laser system, known as AviClear, is being tested for its safety and effectiveness in treating facial papules associated with FFA. The study will monitor how well this specific laser technology works on participants' skin conditions.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will be in this group for up to approximately 30 weeks and complete up to 5 visits
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Cutera Inc.
Industry Sponsor
Citations
Cutera Laser System for Hair Loss · Info for Participants
The Cutera 1726 nm laser system, known as AviClear, is being tested for its safety and effectiveness in treating facial papules associated with FFA. The study ...
Facial Papules in Frontal Fibrosing Alopecia (FFA)
Study Overview. Brief Summary. The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to ...
Novel 1726 nm laser demonstrates durable therapeutic ...
The percentage of subjects clear or almost clear increased from 0% at baseline to 9%, 36.0%, and 41.8% at 4-, 12-, and 26-weeks follow-up. No serious adverse ...
AviClear
Clinical trials demonstrate that current and future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure.1 Further, ...
March 24, 2022 Cutera, Inc. Amogh Kothare VP, Clinical and ...
The 1726 nm laser energy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous ...
Why AviClear?
Engineered with a revolutionary 1726 nm wavelength safe for all skin types, it selectively targets and suppresses the sebaceous glands, reducing acne at the ...
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