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

A Phase 3 Randomized Placebo-Controlled Double-Blind Study of the Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction

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

Study Overview

• Status: Completed
• Conditions: Atrophic Acne Scar
• Intervention / Treatment: Drug: Normal Saline; Device: Artefill

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of Artefill for correction of moderate to severe atrophic acne scars.

The study is divided into two study periods. In Period I, scars meeting the treatment criteria will be individually identified, numbered and mapped using photographs and transparent sheets prior to treatment. This mapping will be used to track individual scars throughout the trial. Four (4) weeks following a baseline qualification visit, subjects randomized to treatment will receive one treatment of Artefill or Control (saline), administered by the Treating Investigator. At 72 hours following injections, subjects will be followed-up by telephone to confirm the occurrence of any AEs. Subjects will return to the clinic at 2 weeks for follow-up evaluation, and then at 4 weeks where subjects may receive one optional touch-up treatment. Subjects receiving touch-up treatment will be followed-up by telephone at 72 hours to confirm the occurrence of any AEs, and return for clinic visits at 6 weeks and 8 weeks. All subjects will then return for clinic follow-up at months 3 and 6 (after last treatment).

Period II is open label and will begin at month 6. Artefill group subjects will return to the clinic for assessments at months 9 and 12 (Track A) and Control group subjects will enter Track B, re-establish baseline, and complete additional month 6 visit activities including Artefill treatment. Subjects will receive touch up (if required) 4 weeks later, and be followed for an additional 12 months.

Subjects will be required to abstain from other aesthetic treatment to their face during the study period and failure to do so will be considered a protocol violation. However, if a subject does receive additional aesthetic or non-aesthetic treatments, available information on such treatment will be collected and the subject will be continued to be followed per protocol. Such subjects will not be excluded from the analysis, but will also be evaluated separately.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
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    • Los Angeles, California, United States, 90036
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    • San Diego, California, United States, 92121
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    • Santa Monica, California, United States, 90404
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  • Florida
    • Miami Beach, Florida, United States, 33137
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    • Saint Petersburg, Florida, United States, 33716
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  • Maryland
    • Glenn Dale, Maryland, United States, 20769
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  • Massachusetts
    • Wellesley, Massachusetts, United States, 02481
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  • Texas
    • Houston, Texas, United States, 77056
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  • Washington
    • Spokane, Washington, United States, 99204
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Normal Saline	Drug: Normal Saline; Administration of up to 2 study treatments administered 6 weeks apart
EXPERIMENTAL: Artefill; Dermal Filler	Device: Artefill; Administration of up to 2 study treatments administered 6 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASRS Responder Rate at 6 Months	Subject considered to be a "responder" if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment).	6 months post-treatment

Collaborators and Investigators

• Sponsor: Suneva Medical, Inc.
• Collaborators: ethica Clinical Research Inc.
• Investigators: Study Director: Nancy Serreta, Suneva Medical

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (ESTIMATE): March 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Acne
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Vasodilator Agents; Protective Agents; Antimutagenic Agents; Polymethyl Methacrylate
• Other Study ID Numbers: SUN-11-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO