A Post Market Device Study for the Treatment of Acne

NCT06469398 | Active Not Recruiting FDA Device

• 1 other identifier: C-22-AC05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Laser Treatment

EXPERIMENTAL

Device: Cutera Laser System

Interventions

Cutera Laser System DEVICE

Subjects will receive up to 6 laser treatments

Laser Treatment

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female or Male, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive).
• 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.
• Has ≥ 10 inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
• 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.
• Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
• 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.
• 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.
• Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
• 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.
• Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.

You may not qualify if:

• 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.
• 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.
• Still healing from another treatment in the target area according to investigator's discretion.
• Currently pregnant or planning on becoming pregnant anytime during the duration of the study.
• Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that may preclude treatments, photos, or accurate acne lesion assessments in the target area.
• Currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
• 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.
• Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox or mild oral anti-anxiety or pain medication, if administered.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (3)

Dermatology of Boca

Boca Raton, Florida, 33431, United States

Location

Schweiger Dermatology PC, Reseach Division

Hackensack, New Jersey, 07601, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: July 21, 2022
• Primary Completion: March 31, 2025
• Study Completion: August 18, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)