Cutera Laser System for Acne

Not currently recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Cutera Inc.

Disqualifiers: Mild acne, Pregnancy, Skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the Cutera laser system for treating acne vulgaris, a common skin condition causing pimples and redness. Participants will receive laser treatments to determine if it reduces moderate to severe facial acne. Individuals with at least 10 inflamed pimples on their face may qualify for this study. Participants must avoid sun exposure, maintain their current skincare routine, and consent to having their photos taken. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance acne treatment options.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current acne medications. You must keep using the same acne treatment regimen for at least 2 weeks before joining the study and throughout the study, unless the investigator approves a change.

What prior data suggests that the Cutera laser system is safe for treating acne?

Research shows that the Cutera Laser System is safe for treating acne. Previous studies found that the device can use its laser functions without causing serious harm. Another study confirmed that the system is effective and safe for treating acne over the long term, from mild to severe cases.

However, some side effects can occur. People have reported discomfort, pain, swelling, redness, and changes in skin color after using similar laser treatments. These effects are common with laser therapies and usually resolve on their own.

Overall, evidence suggests that the Cutera Laser System is generally well-tolerated, but it's important to consider these possible side effects before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cutera Laser System is unique because it uses laser technology to target acne in a way that's different from traditional treatments like topical creams and oral medications. Most acne treatments focus on reducing oil production or bacteria on the skin's surface. However, the Cutera Laser System works by penetrating deeper layers of the skin to reduce inflammation and kill bacteria directly at the source, potentially leading to faster and more effective results. Researchers are excited about this treatment because it offers a non-invasive option that might minimize the side effects often associated with other acne treatments, such as skin irritation or dryness.

What evidence suggests that the Cutera Laser System is effective for acne?

Research has shown that the Cutera laser system, which participants in this trial will receive, effectively treats acne. One study found that 79.8% of patients experienced at least a 50% improvement in their acne after 12 weeks, increasing to 91.5% after a year. Another report indicated that the laser treatment significantly reduces the severity and frequency of acne in about 90% of cases. These findings suggest that the Cutera laser system can lead to noticeable and lasting improvement in acne symptoms for many people. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to limit my sun exposure and use SPF 30+ sunscreen daily during the study.

I can follow the treatment plan and care instructions.

Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes

Exclusion Criteria

My acne severity on my face is mild or almost clear.

I haven't been part of a drug or device trial in the last 30 days.

Still healing from another treatment in the target area according to investigator's discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Cutera laser treatment for acne vulgaris

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cutera Laser System

Trial Overview 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.

How Is the Trial Designed?

Group I: Laser Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cutera Inc.

Lead Sponsor

Trials

44

Recruited

1,200+

Citations

1. jaad.org jaad.org/article/S0190-9622(25)02900-7/fulltext

Safe and effective acne treatment across skin types with a ... At 12 weeks, 79.8% demonstrated ≥50% improvement in inflammatory lesion counts, which increased to 91.5% at 52 weeks. The proportion of patients ...

2. cutera.com cutera.com/us-en/2022/09/08/cutera-announces-over-1000-aviclear-acne-treatments-performed/

Cutera Announces Over 1000 AviClear™ Acne Treatments ... Through the application of the company's proprietary technologies, AviClear significantly reduces the severity and frequency of acne, with 90% ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K213461.pdf

March 24, 2022 Cutera, Inc. Amogh Kothare VP, Clinical and ... The study's primary effectiveness objective was to show more that than 50% of subjects enrolled were Responders who achieved Treatment Success, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189219/

Established and Emerging Laser Treatments for Acne ... Of the 89 patients who completed three treatments, 32.6 percent were “responders” (≥50% reduction in active inflammatory lesions) at four weeks, 79.8 percent at ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962223010757

Novel 1726 nm laser demonstrates durable therapeutic ... Results. Following final treatment, ≥50% reduction in active acne inflammatory lesions was 32.6% at 4-weeks follow-up, increasing further to 79.8% and 87.3% at ...

6. cutera.com cutera.com/uk-en/usage-and-safety-guide/

Cutera Devices Usage & Safety Guide Important Safety Information: The following adverse effects can occur when treating with the Secret RF: Discomfort; Pain; Swelling; Redness; Skin color changes ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf25/K251149.pdf

July 11, 2025 Cutera, Inc. Julia Brown Sr. Manager ... Accordingly, the modified device can be safely and effectively used for the long-term treatment of mild to severe inflammatory acne vulgaris.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/21/NCT03430921/Prot_001.pdf

C-17-ML03 Protocol Title: Open-label, Prospective, ... The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse ...

9. cutera.com cutera.com/us-en/products/aviclear/

AviClear AviClear is the original FDA-cleared energy device designed with a 1726 nm wavelength to treat mild to severe acne at the source. Learn more.