A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars

Exclusion Criteria

• •Female subjects that are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
• •Undergone facial treatments with any prohibited treatment/procedures and/or use of any other prohibited treatment/procedure.
• •Excisional facial surgery (such as Blepharoplasty, Face Lift, Rhinoplasty) of the face ≤ 6 months prior to study enrollment or plans for facial surgery during the study.
• •History of bleeding disorders.
• •Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to the proposed treatment or require interfering topical, systemic or surgical therapy.
• •Recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed treatment areas. Clinically significant acne is defined as a patient whom has ≥3 active inflammatory acne lesions in the treatment areas.
• •History of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegeners, TB) or connective tissue diseases (e.g., lupus, dermatomyositis).
• •Hypertrophic acne scars, any evidence of keloid scarring in the treatment area.
• •Known hypersensitivity or previous allergic reaction to any of the components of the study device (including lidocaine or any amide-based anesthetic), or has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
• •Undergone or be planning to undergo desensitization injections to meat products.
• •Unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
• •Evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
• •Use of an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
• •Exhibits additional physical attributes which prevent the assessment or treatment of the atrophic scars, as judged by the Investigator, such as excessive hair, traumatic or surgical scars, excessive hyperpigmentation in the treatment area, etc.
• •Has a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
• •An employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.