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Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Suneva Medical, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Suneva Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01559922
First received: March 15, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to determine whether Artefill is safe and effective for the correction of atrophic facial acne scars.


Condition Intervention Phase
Acne Scarring of the Face
Drug: Normal Saline
Device: Artefill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Placebo-Controlled Double-Blind Study of the Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction

Resource links provided by NLM:


Further study details as provided by Suneva Medical, Inc.:

Primary Outcome Measures:
  • Rate of ASRS-based success [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 12 months post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 177
Study Start Date: February 2012
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Normal Saline
Drug: Normal Saline
Administration of up to 2 study treatments administered 6 weeks apart
Experimental: Artefill Device: Artefill
Administration of up to 2 study treatments administered 6 weeks apart

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be an outpatient, male or female subjects of any race, 18 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.
  2. Subject must have moderate to severe atrophic acne scars
  3. Subject must desire correction of his/her moderate to severe acne scarring.
  4. Subjects of all Fitzpatrick skin types are eligible.
  5. Subject must be willing to withhold additional aesthetic therapies to the face (eg, other soft tissue fillers: Restylane, Radiesse, Sculptra, and/or any resurfacing procedures for the duration of the study.
  6. Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
  7. Subject must 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:

  1. 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.
  2. Undergo facial treatments with any listed of the prohibited treatment/procedures and/or use of any other prohibited treatment/procedure within certain time periods.
  3. Have 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.
  4. Have a 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 either the right or left treatment area.
  5. Have a history of systemic granulomatous diseases active or inactive (eg, Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (eg, lupus, dermatomyositis, etc.).
  6. Have hypertrophic acne scars, any evidence of keloid scarring, predominantly icepick scarring (defined as more than half of all scar area in either the left or right or treatment area) or sinus tract scars.
  7. Have a 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559922

Locations
United States, California
Beverly Hills, California, United States
San Diego, California, United States
Santa Monica, California, United States
United States, Florida
Miami Beach, Florida, United States
St.Petersburg, Florida, United States
United States, Massachusetts
Wellesley, Massachusetts, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Suneva Medical, Inc.
  More Information

No publications provided

Responsible Party: Suneva Medical, Inc.
ClinicalTrials.gov Identifier: NCT01559922     History of Changes
Other Study ID Numbers: SUN-11-001
Study First Received: March 15, 2012
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Suneva Medical, Inc.:
Acne

Additional relevant MeSH terms:
Polymethyl Methacrylate
Antimutagenic Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014