Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether Artefill is safe and effective for the correction of atrophic facial acne scars.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- ASRS Responder Rate at 6 Months [6 months post-treatment]
Subject considered to be a "responder" if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment).
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Call Suneva for Info | Beverly Hills | California | United States | 90210 |
| 2 | Call Suneva for Info | Los Angeles | California | United States | 90036 |
| 3 | Call Suneva for Info | San Diego | California | United States | 92121 |
| 4 | Call Suneva for Info | Santa Monica | California | United States | 90404 |
| 5 | Call Suneva for Info | Miami Beach | Florida | United States | 33137 |
| 6 | Call Suneva for Info | Saint Petersburg | Florida | United States | 33716 |
| 7 | Call Suneva for Info | Glenn Dale | Maryland | United States | 20769 |
| 8 | Call Suneva for Info | Wellesley | Massachusetts | United States | 02481 |
| 9 | Call Suneva for Info | Houston | Texas | United States | 77056 |
| 10 | Call Suneva for Info | Spokane | Washington | United States | 99204 |
Sponsors and Collaborators
- Suneva Medical, Inc.
- ethica Clinical Research Inc.
Investigators
- Study Director: Nancy Serreta, Suneva Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SUN-11-001
Study Results
Participant Flow
| Recruitment Details | 199 subjects were enrolled into the Screening phase. 175 subjects were randomized, with a total of 147 subjects receiving study treatment. Data presented are from all Randomized/Treated subjects (i.e., n=147). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Artefill |
|---|---|---|
| Arm/Group Description | Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart | Artefill: Administration of up to 2 study treatments administered 6 weeks apart |
| Period Title: Overall Study | ||
| STARTED | 50 | 97 |
| COMPLETED | 46 | 87 |
| NOT COMPLETED | 4 | 10 |
Baseline Characteristics
| Arm/Group Title | Placebo | Artefill | Total |
|---|---|---|---|
| Arm/Group Description | Normal Saline Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart | Artefill: Administration of up to 2 study treatments administered 6 weeks apart | Total of all reporting groups |
| Overall Participants | 50 | 97 | 147 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
50
100%
|
97
100%
|
147
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
30
60%
|
60
61.9%
|
90
61.2%
|
| Male |
20
40%
|
37
38.1%
|
57
38.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
2
2.1%
|
2
1.4%
|
| Asian |
4
8%
|
4
4.1%
|
8
5.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
1%
|
1
0.7%
|
| Black or African American |
8
16%
|
20
20.6%
|
28
19%
|
| White |
38
76%
|
70
72.2%
|
108
73.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
13
26%
|
20
20.6%
|
33
22.4%
|
| Not Hispanic or Latino |
37
74%
|
77
79.4%
|
114
77.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
50
100%
|
97
100%
|
147
100%
|
Outcome Measures
| Title | ASRS Responder Rate at 6 Months |
|---|---|
| Description | Subject considered to be a "responder" if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment). |
| Time Frame | 6 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Population included only subjects that passed screening |
| Arm/Group Title | Placebo | Artefill |
|---|---|---|
| Arm/Group Description | Normal Saline Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart | Artefill: Administration of up to 2 study treatments administered 6 weeks apart |
| Measure Participants | 50 | 97 |
| Number (95% Confidence Interval) [percentage of participants] |
32.4
64.8%
|
67.4
69.5%
|
Adverse Events
| Time Frame | 12 months post treatment | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo | Artefill | ||
| Arm/Group Description | Normal Saline Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart | Artefill: Administration of up to 2 study treatments administered 6 weeks apart | ||
All Cause Mortality |
||||
| Placebo | Artefill | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo | Artefill | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/50 (4%) | 3/97 (3.1%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 1/50 (2%) | 1 | 0/97 (0%) | 0 |
| Infections and infestations | ||||
| Meningitis | 0/50 (0%) | 0 | 1/97 (1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 0/50 (0%) | 0 | 1/97 (1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast Cancer (recurrent) | 1/50 (2%) | 1 | 0/97 (0%) | 0 |
| Psychiatric disorders | ||||
| Depression | 0/50 (0%) | 0 | 1/97 (1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Artefill | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/97 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Suneva, as the Sponsor, has a proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation among multiple investigators and sites and Suneva personnel. Authorship will be established prior to the writing of the manuscript. As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multi-center study except as agreed with Suneva.
Results Point of Contact
| Name/Title | Suneva Medical,Inc. |
|---|---|
| Organization | Suneva Medical, Inc. |
| Phone | |
| Acne.ScarInfo@sunevamedical.com |
- SUN-11-001