A Device Study for the Treatment of Acne

NCT04695691 | Completed Results FDA Device

• 1 other identifier: C-20-PAC01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 7

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)

• Percentage of Participants Achieving Treatment Success

  Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline

  12 weeks post final treatment, up to 24 weeks

Study Arms (1)

Laser Treatment

EXPERIMENTAL

Device: Cutera Laser System

Interventions

Cutera Laser System DEVICE

Subjects will receive 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, 16 to 60 years of age (inclusive)
• Fitzpatrick Skin Type I-VI
• Has clinically diagnosed acne vulgaris of severity grade 2 - 4 on the face using the Investigator's Global Assessment Scale.
• Has 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 to stop using topical retinoids and other acne medications for 1 month (30 days) prior to baseline and for the duration of the study. If the acne medication is topical, the washout applies to use on the face only.
• 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 sunscreen of SPF 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.

You may not qualify if:

• Has clinically diagnosed acne vulgaris of severity grade 0 or 1 on the face 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 3 months of study participation including chemical peel, dermabrasion, 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 3 months of study participation and for the duration of the study.
• Prior injection of collagen, hyaluronic acid filler or other dermal filler in the target area within 6 weeks of study participation.
• Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
• History of malignant tumors in the target area.
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris in the target area (okay if shaved).
• Pregnant and/or breastfeeding or planning to become pregnant during the study.
• Presence of any skin condition in the target area (e.g. eczema, psoriasis, dermatitis, rash, papulo-pustular rosacea, infection) that would interfere with the diagnosis or assessment of acne vulgaris.
• Any medical condition that, in the opinion of the Investigator, would interfere with patient's participation in the full study protocol (e.g. severe Diabetes Mellitus or Cardiovascular Disease).
• Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
• History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (7)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Blackhawk Plastic Surgery

Danville, California, 94506, United States

Location

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

Laser and Skin Surgery Center of Northern CA

Sacramento, California, 95816, United States

Location

Kwan Dermatology

San Francisco, California, 94108, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146, United States

Location

Skin Laser & Surgery Specialists, a Division of Schweiger Dermatology

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director Clinical Research
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome Assessor is blinded to study design and time point being assessed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 5, 2021
• Study Start: December 15, 2020
• Primary Completion: October 9, 2021
• Study Completion: December 7, 2022
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)