A Device Study for the Treatment of Acne

Exclusion Criteria

• •1. Has clinically diagnosed acne vulgaris of severity grade 0 or 1 on the face using the Investigator's Global Assessment Scale.
• •2. 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.
• •3. 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.
• •4. Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
• •5. Prior injection of collagen, hyaluronic acid filler or other dermal filler in the target area within 6 weeks of study participation.
• •6. Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
• •7. History of malignant tumors in the target area.
• •8. 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).
• •9. Pregnant and/or breastfeeding or planning to become pregnant during the study.
• •10. 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.
• •11. 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).
• •12. Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
• •13. History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• •14. History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• •15. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• •16. 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.
• •17. 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.
• •18. History of diagnosed pigmentary disorders (including vitiligo) in the target area.
• •19. Excessively tanned on the face or unable/unlikely to refrain from tanning on the face during the study.
• •20. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.