The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area

NCT02642627 | Completed Results

• 1 other identifier: SUN-1504
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety of Bellafill for correction of distensible atrophic acne scars in the full facial area. All enrolled subjects will receive initial treatment with Bellafill, as well as touch-up treatments (if necessary to achieve optimal correction). Subjects will be evaluated at Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.

Conditions

Atrophic Acne Scarring

Outcome Measures

Primary Outcomes (1)

• Change on the Acne Scar Assessment Scale (ASAS)

  A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen. Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow). Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow). Moderate: More than half of the depressions are apparent with direct lighting (deep). Severe: All or almost all the lesions can be seen with direct lighting (deep)

  Month 1, 4 and 7

Secondary Outcomes (1)

• Adverse Events

  month 7

Study Arms (1)

Bellafill Injections

EXPERIMENTAL

Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.

Device: Bellafill

Interventions

Bellafill DEVICE

Bellafill Injections

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (treatment scars) in in the facial area.
• Subject desires correction of his/her atrophic acne scarring.
• All Fitzpatrick skin types are eligible.
• 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 5.4) 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.

You may not qualify if:

• 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 within certain time periods as listed in Protocol Section 5.4.
• Excisional facial surgery (such as Blepharoplasty, Face Lift, Rhinoplasty) of the face less than 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.

Sponsors & Collaborators

• Suneva Medical, Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (1)

Call Suneva for Info

Houston, Texas, 77494, United States

Location

Related Publications (1)

• Joseph JH, Shamban A, Eaton L, Lehman A, Cohen S, Spencer J, Bruce S, Grimes P, Tedaldi R, Callender V, Werschler P. Polymethylmethacrylate Collagen Gel-Injectable Dermal Filler for Full Face Atrophic Acne Scar Correction. Dermatol Surg. 2019 Dec;45(12):1558-1566. doi: 10.1097/DSS.0000000000001863.

  PMID: 30829754 DERIVED

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Suneva Medical

alehman@sunevamedical.com

858-324-6268

Study Officials

• Nancy Seretta

  Suneva Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: December 30, 2015
• Study Start: November 18, 2015
• Primary Completion: January 27, 2017
• Study Completion: January 27, 2017
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)