A Randomized, Controlled, Split Face Study of a 1726 nm Laser for the Treatment of Acne Vulgaris

Cutera Inc.2 sites in 1 country30 target enrollmentJuly 27, 2022

ConditionsAcne Vulgaris

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acne Vulgaris
Sponsor: Cutera Inc.
Enrollment: 30
Locations: 2
Primary Endpoint: Percent of subjects having at least a 1 point reduction on the Investigator Global Assessment Scale
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the onset, duration, efficacy and safety of the laser for the treatment of acne vulgaris.

Registry

clinicaltrials.gov

Start Date

July 27, 2022

End Date

October 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Cutera Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female or Male, 16 to 50 years of age (inclusive).
•Fitzpatrick Skin Type I-VI
•Has clinically diagnosed acne vulgaris of moderate to severe on each hemiface and inflammatory acne lesions as determined by the blinded trained investigator (or qualified designee) using the Investigator's Global Assessment Scale.
•Subject (and legally authorized representative/substitute decision maker if subject is incapable of providing informed consent) must be able to read, speak, and understand English and sign the Informed Consent Form.
•Willing to stop using topical acne medications on the face for 2 weeks prior to baseline and systemic acne medications for 1 month prior to baseline and for the duration of the study.
•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 approved sunblock or sunscreen of SPF (Skin Protection Factor) 30 or higher on the face every day for the duration of the study, including the follow-up period.
•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.

Exclusion Criteria

•Has clinically diagnosed acne vulgaris of severity grade of clear, almost clear, or mild on at least one hemiface as determined by the blinded trained investigator (or qualified designee) 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.
•Prior treatment to the target area within 1 month of study participation including chemical peel, dermabrasion/microdermabrasion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic therapy, or acne surgery.
•Prior injection of botulinum toxin in the target area within 1 month of study participation and for the duration of the study.
•Prior injection of collagen, hyaluronic acid filler or other dermal/tissue filler in the target area within 2 weeks of study participation.
•Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
•Started or changed hormonal contraception within 6 months of study participation or intends to start or change hormonal contraception through duration of the study. If subject has not changed hormonal contraception within 6 months of study participation and has intent of continuation through duration of this study, ok to enroll.
•History of malignant tumors in the target area.
•Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) or facial adornments (studs, piercings, tattoos) that may preclude treatments, photos or accurate lesion assessments in the target area.
•Pregnant and/or breastfeeding or planning to become pregnant during the study.