A Study of a Laser for the Treatment of Acne Vulgaris

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.
• •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.
• •Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox (or similar) if administered.
• •Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the target area, unless treatment is conducted following a prophylactic regimen.
• •History of radiation to the target area, currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
• •History of diagnosed pigmentary disorders (including vitiligo) in the target area.
• •Facial tan or unable/unlikely to refrain from tanning on the face during the study.
• •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.