A Study of a Laser for the Treatment of Acne Vulgaris

NCT05430464 | Unknown FDA Device

• 1 other identifier: C-22-AC04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Percent of subjects having at least a 1 point reduction on the Investigator Global Assessment Scale

  12 weeks

Study Arms (2)

1726nm Laser Treatment

EXPERIMENTAL

Device: 1726nm Laser System

Sham Laser Treatment

SHAM COMPARATOR

Device: Sham Laser System

Interventions

1726nm Laser System DEVICE

Subjects will receive 1726nm laser treatments on one side of the face

1726nm Laser Treatment

Sham Laser System DEVICE

Subjects will receive sham laser treatments on the other side of the face.

Sham Laser Treatment

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (2)

Canadian Dermatology Centre

Toronto, Ontario, M3B 0A7, Canada

RECRUITING

Windsor Clinical Research

Windsor, Ontario, N8W 5L7, Canada

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Spencer Royea

CONTACT

415-657-5531; sroyea@cutera.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 27, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)