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Procedure

Cutera Laser System for Acne

N/A
Waitlist Available
Research Sponsored by Cutera Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an investigator approved sunblock or sunscreen of SPF 30 or higher on the face every day for the duration of the study, including the follow-up period
Female or Male, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive)
Must not have
Has clinically diagnosed acne vulgaris of severity grade 0, 1, 2 (clear, almost clear, mild) on the face based on photographic review by expert dermatologist grader(s) using the Investigator's Global Assessment Scale
Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox or mild oral anti-anxiety or pain medication, if administered
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post final treatment
Awards & highlights

Summary

This trial will test if the Cutera laser system is safe and effective for treating acne.

Who is the study for?
This trial is for people aged 16-60 with moderate to severe acne (grade 3-4), who are willing to limit sun exposure, follow a specific skincare routine, and avoid other acne treatments during the study. Pregnant individuals or those with mild acne, recent facial treatments, excessive facial hair, or certain medical conditions cannot participate.
What is being tested?
The Cutera laser system's safety and effectiveness in treating acne vulgaris are being tested. Participants will undergo this treatment while following strict guidelines regarding sun exposure and skincare regimens throughout the study period.
What are the potential side effects?
While not explicitly listed here, potential side effects may include skin irritation, redness, swelling at the treatment site from the laser therapy. The exact side effects will be monitored and recorded as part of evaluating the device's safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to limit my sun exposure and use SPF 30+ sunscreen daily during the study.
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I am between 16 and 60 years old with any skin type.
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I have 10 or more red, swollen acne spots on my face.
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I have moderate to severe acne on my face, confirmed by a dermatologist.
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I (and my guardian if I'm under 18) can understand and speak English and can sign the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My acne severity on my face is mild or almost clear.
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I am allergic or sensitive to certain anxiety or pain medications.
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I am currently being treated for skin cancer or receiving chemotherapy for any cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post final treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post final treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Subjects Who are Responders

Trial Design

1Treatment groups
Experimental Treatment
Group I: Laser TreatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cutera Laser System
2020
N/A
~110

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Who is running the clinical trial?

Cutera Inc.Lead Sponsor
43 Previous Clinical Trials
1,136 Total Patients Enrolled
1 Trials studying Acne
4 Patients Enrolled for Acne
~16 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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