A Phase 3 interventional study of Normal Saline and Artefill in Atrophic Acne Scar, sponsored by Suneva Medical, Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Suneva Medical, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether Artefill is safe and effective for the correction of atrophic facial acne scars.
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.
Exclusion Criteria:
Normal Saline
Drug: Normal Saline
Dermal Filler
Device: Artefill
Administration of up to 2 study treatments administered 6 weeks apart
Administration of up to 2 study treatments administered 6 weeks apart
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).
Time frame: 6 months post-treatment
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).
| Milestone | Placebo | Artefill |
|---|---|---|
| Started | 50 | 97 |
| Completed | 46 | 87 |
| Not completed | 4 | 10 |
Subject considered to be a "responder" if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment).
| percentage of participants | Placebo | Artefill |
|---|---|---|
| ASRS Responder Rate at 6 Months | 32.4 (17.3 to 52.2) | 67.4 (51.3 to 80.2) |
Collected over 12 months post treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 2/50 (4%) | 0/50 (0%) |
| Artefill | — | 3/97 (3.1%) | 0/97 (0%) |
| Event | Placebo | Artefill |
|---|---|---|
| Cholecystitis acuteHepatobiliary disorders | 1/50 | 0/97 |
| Breast Cancer (recurrent)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/50 | 0/97 |
| Back painMusculoskeletal and connective tissue disorders | 0/50 | 1/97 |
| DepressionPsychiatric disorders | 0/50 | 1/97 |
| MeningitisInfections and infestations | 0/50 | 1/97 |
| Age, Categorical(Participants) | Placebo | Artefill | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 97 | 147 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | Artefill | Total |
|---|---|---|---|
| Female | 30 | 60 | 90 |
| Male | 20 | 37 | 57 |
| Race (NIH/OMB)(Participants) | Placebo | Artefill | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 4 | 4 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 8 | 20 | 28 |
| White | 38 | 70 | 108 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Artefill | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 20 | 33 |
| Not Hispanic or Latino | 37 | 77 | 114 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Artefill | Total |
|---|---|---|---|
| United States | 50 | 97 | 147 |
Plan to share: No
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Suneva Medical, Inc.