Cutera Laser System for Acne

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris.

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 data supports the effectiveness of the Cutera Laser System treatment for acne?

Research shows that various laser treatments, like the 577-nm high-power laser and the 1,450 nm diode laser, are effective in treating acne by reducing inflammation and shrinking oil glands. These findings suggest that laser systems, including the Cutera Laser System, may help improve acne symptoms. ^{1 2 3 4 5}

How does the Cutera Laser System treatment for acne differ from other treatments?

The Cutera Laser System for acne is unique because it uses a specific type of laser technology that targets acne-causing bacteria and sebaceous glands, potentially offering a more focused and less invasive approach compared to traditional methods. This system may provide an alternative for those who have not responded well to conventional acne treatments. ^{1 2 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Laser Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cutera Inc.

Lead Sponsor

Trials

44

Recruited

1,200+

References

1. England pubmed.ncbi.nlm.nih.gov

577-nm high-power optically pumped semiconductor laser is safe and effective in the treatment of inflammatory acne: a prospective, single-center, split-face comparative study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Acne Treatment With Light Absorbing Gold Microparticles and Optical Pulses: An Open-Label European Multi-Centered Study in Moderate to Moderately Severe Acne Vulgaris Patients. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of a 1,450 nm diode laser on facial sebum excretion. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of the clinical efficacy of the 1,450 nm laser in acne vulgaris: a randomized split-face, investigator-blinded clinical trial. [2015]

5. England pubmed.ncbi.nlm.nih.gov

The quantitative analysis of low-concentration (2%) ALA-PDT assisted with Q-switch 1064-nm Nd:YAG laser for acne vulgaris treatment. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Acne vulgarism treatment using ultra-short laser pulse generated by micro- and nano-ring resonator system. [2015]

7. India pubmed.ncbi.nlm.nih.gov

Comparison of Q-Switched 1064-nm Nd: YAG laser and fractional CO2 laser efficacies on improvement of atrophic facial acne scar. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and efficacy of a fractional picosecond 1064 nm laser for post-acne erythema in adult Chinese patients. [2023]