Evaluation of a Photopneumatic System for the Treatment of Acne

The primary aims of the study will be to demonstrate the safety and efficacy of using a photopneumatic system for treatment of mild to moderate acne on the face or body - including neck, chest, and back - of up to 24 subjects. To support this clinical assessment, the affected areas to be treated will be documented at baseline, at each subsequent treatment visit (up to 6 treatments), and at one (1) month and three (3) months following final treatment.

Inclusion criteria

• Fitzpatrick skin type I-VI.
• Male or female.
• Subjects must be between 18 and 55 years of age.
• Subjects must have mild to moderate acne (defined as 15 or more inflammatory or non-inflammatory lesions).
• Subjects must read, understand, and sign the informed consent form.
• Subjects must be willing and able to comply with all follow-up requirements.

Exclusion criteria

• Subjects must not have active localized or systemic infections.
• Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
• Subjects must not have received microdermabrasion within one (1) month prior to enrollment.
• Subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment.
• Subjects must not have received laser or light treatment within the last three (3) months.
• Subjects must not have received dermabrasion, TCA peel greater than 20%, botulinum toxin type A, dermal fillers, photodynamic therapy (PDT), or cosmetic surgery within the last six (6) months .
• Subjects must not be currently taking or have used isotretinoin (e.g. Accutane) within six (6) months prior to enrollment.
• Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
• Subjects must not have had previous ablative laser treatment.
• Subjects must refrain from excessive sun exposure during participation in this study.
• Subjects must not have any condition that results in photosensitivity or be taking any medication containing aminolevulinic acid (E.g. Levulan).
• Subjects must not be a current or past smoker of cigarettes and/or cigars.
• Subjects must not be pregnant.
• Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.