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

NCT01559922 | Completed Phase 3 Results

• 1 other identifier: SUN-11-001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Atrophic Acne Scar

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal Saline

Drug: Normal Saline

Artefill

EXPERIMENTAL

Dermal Filler

Device: Artefill

Interventions

Normal Saline DRUG

Administration of up to 2 study treatments administered 6 weeks apart

Placebo

Artefill DEVICE

Administration of up to 2 study treatments administered 6 weeks apart

Artefill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suneva Medical, Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (10)

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Beverly Hills, California, 90210, United States

Location

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Los Angeles, California, 90036, United States

Location

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San Diego, California, 92121, United States

Location

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Santa Monica, California, 90404, United States

Location

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Miami Beach, Florida, 33137, United States

Location

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St. Petersburg, Florida, 33716, United States

Location

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Glenn Dale, Maryland, 20769, United States

Location

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Wellesley, Massachusetts, 02481, United States

Location

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Houston, Texas, 77056, United States

Location

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Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Suneva Medical,Inc.
• Organization: Suneva Medical, Inc.

Acne.ScarInfo@sunevamedical.com

Study Officials

• Nancy Serreta

  Suneva Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: February 1, 2014
• Last Updated: November 1, 2019
• Results First Posted: February 14, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)