Overview

This trial is active, not recruiting.

Condition acne scarring of the face
Treatments normal saline, artefill
Phase phase 3
Sponsor Suneva Medical, Inc.
Start date February 2012
End date April 2013
Trial size 177 participants
Trial identifier NCT01559922, SUN-11-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Normal Saline
normal saline
Administration of up to 2 study treatments administered 6 weeks apart
(Experimental)
artefill
Administration of up to 2 study treatments administered 6 weeks apart

Primary Outcomes

Measure
Rate of ASRS-based success
time frame: 6 months post-treatment
Adverse Events
time frame: 12 months post-treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase 3 Randomized Placebo-Controlled Double-Blind Study of the Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Suneva Medical, Inc..