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

Study Overview
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Brief Summary
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This is an open-label, randomized, multicenter, prospective trial assessing the efficacy and safety of microneedling treatment alone vs. microneedling treatment followed by treatment with Bellafill for correction of distensible atrophic facial acne scars.

Detailed Description
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The study is divided into two study Periods. In Period I, subjects will attend a Screening visit (Week -4) and undergo the Bellafill skin test. At Visit 1 (Day 0), all subjects will commence microneedling treatment for their atrophic acne scars. Subjects will then return to the clinic at Week 3 and Week 6 (Visits 2 and 3, respectively) for follow-up evaluation and additional cycles of microneedling treatment. At Week 12 (Visit 4), all subjects commence Period II and are randomized to Bellafill Treatment (Track A) or to No Treatment (Track B): Track A: Consists of three (3) study visits. At Visit 4, subjects randomized to the Bellafill group will receive treatment with Bellafill for their atrophic acne scars. Subjects return for Visit 5A (Month 1 after randomization) for evaluation and follow-up, and will receive touch-up injections with Bellafill to achieve optimal correction (if necessary). Subjects will then be followed-up at Visits 6A and 7A which will occur at Month 3 and Month 6, respectively, after their last Bellafill treatment. Track B: Consists of one (1) study visit. At Visit 4, subjects randomized to the No Treatment group will complete visit evaluations and then return for follow-up at Visit 5B (approx. Month 3 after randomization).

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

Conditions
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Atrophic Acne Scars

Intervention / Treatment
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* Procedure: Microneedling
* Device: Microneedling followed by Bellafill treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient, male or female subjects of any race, 21 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study. Negative response to the Bellafill Skin Test. Presence of ≥4 distensible atrophic acne scars located within the facial treatment area. Subject desires correction of his/her atrophic acne scarring. All Fitzpatrick skin types are eligible. Subjects with a history of HSV-1 (oral herpetic outbreak) willing to accept prophylactic treatment with antiviral medication. Willing to withhold additional aesthetic therapies to the proposed treatment area (e.g., other soft tissue fillers such as hyaluronic acid, and/or any resurfacing procedures (as described in Protocol Section 5.3) for the duration of the study. Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator. Sign an IRB-approved Informed Consent Form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) Form prior to any study-related procedures being performed. 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microneedling Only<br>All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction. | Procedure: Microneedling<br> <br> |
| Experimental: Microneedling followed by Bellafill treatment<br>Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction. | Device: Microneedling followed by Bellafill treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acne Scar Assessment Scale (ASAS) | • Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe | 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm | 
| Physician Global Aesthetic Improvement Scale (PGAIS) | The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse | From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm | 
| Subject Global Aesthetic Improvement Scale (SGAIS) | The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse | From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm | 
| Quality of Life Impact Scar (QOLIS) | Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7. | 6-months for the Treatment arm and 3 months for the Microneedling only arm | 
| Number of Subjects With Adverse Events |  | 6-months |