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

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ClinicalTrials.gov Identifier: NCT02642627
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
ethica Clinical Research Inc.
Information provided by (Responsible Party):
Suneva Medical, Inc.

Tracking Information
First Submitted Date  ICMJE December 28, 2015
First Posted Date  ICMJE December 30, 2015
Last Update Posted Date May 10, 2017
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
Acne Scar Assessment Scale (ASAS) [ Time Frame: 6 months post-injection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02642627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
Adverse Events [ Time Frame: Up until 6-months post-treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area
Official Title  ICMJE The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrophic Acne Scarring
Intervention  ICMJE Device: Bellafill
Study Arms  ICMJE Experimental: Bellafill Injections
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.
Intervention: Device: Bellafill
Publications * 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 Feb 15. doi: 10.1097/DSS.0000000000001863. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2016)
41
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2015)
50
Actual Study Completion Date  ICMJE January 30, 2017
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (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.

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 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.
  • An employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02642627
Other Study ID Numbers  ICMJE SUN-1504
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suneva Medical, Inc.
Study Sponsor  ICMJE Suneva Medical, Inc.
Collaborators  ICMJE ethica Clinical Research Inc.
Investigators  ICMJE
Study Director: Nancy Seretta Suneva Medical
PRS Account Suneva Medical, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP