Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction
This study is ongoing, but not recruiting participants.
Sponsor:
Suneva Medical, Inc.
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
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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:
- 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.
- Subject must have moderate to severe atrophic acne scars
- Subject must desire correction of his/her moderate to severe acne scarring.
- Subjects of all Fitzpatrick skin types are eligible.
- 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.
- Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
- 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:
- 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.
- Undergo facial treatments with any listed of the prohibited treatment/procedures and/or use of any other prohibited treatment/procedure within certain time periods.
- 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.
- 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.
- Have a history of systemic granulomatous diseases active or inactive (eg, Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (eg, lupus, dermatomyositis, etc.).
- 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.
- 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
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:
|
Acne Vulgaris Cicatrix Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Fibrosis Pathologic Processes |
Polymethyl Methacrylate Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antimutagenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013