A Post Market Device Study for the Treatment of Acne

A Post Market Study of a Laser System for the Treatment of Acne Vulgaris

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

Study Overview

• Status: Active, not recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Device: Cutera Laser System

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Dermatology of Boca
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Schweiger Dermatology PC, Reseach Division
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female or Male, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive).
2. Has clinically diagnosed acne vulgaris of severity grade 3 - 4 (moderate to severe) on the face based on photographic review by expert dermatologist grader(s) using the Investigator's Global Assessment Scale.
3. Has ≥ 10 inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
4. Subject (and parent or legal guardian if subject is a minor under age 18) must be able to read, speak, and understand English and sign the Informed Consent Form.
5. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
6. 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.
7. Must maintain the same acne treatment regimen, including topical and systemic medications for at least 2 weeks prior to enrollment, and for the duration of the study, including the follow-up period unless approved by the Investigator.
8. Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
9. Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study unless approved by Investigator.
10. Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.

Exclusion Criteria:

1. 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.
2. 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.
3. Still healing from another treatment in the target area according to investigator's discretion.
4. Currently pregnant or planning on becoming pregnant anytime during the duration of the study.
5. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that may preclude treatments, photos, or accurate acne lesion assessments in the target area.
6. Currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
7. As per the Investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study or might interfere with patient's participation in the full study protocol.
8. Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox or mild oral anti-anxiety or pain medication, if administered.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Treatment	Device: Cutera Laser System; Subjects will receive up to 6 laser treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects Who are Responders	The primary outcome measure to evaluate the efficacy of the Cutera device is the percent of subjects who are responders at 12 weeks post final treatment, where a responder is defined as ≥ 1-point reduction on the Investigator's Global Assessment scale at follow up compared to baseline.	12 weeks post final treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): August 18, 2025

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: C-22-AC05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes