Trial Outcomes & Findings for Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction (NCT NCT01559922)
NCT ID: NCT01559922
Last Updated: 2019-11-01
Results Overview
Subject considered to be a "responder" if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
6 months post-treatment
Results posted on
2019-11-01
Participant Flow
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).
Participant milestones
| Measure |
Placebo
Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
|
Artefill
Artefill: Administration of up to 2 study treatments administered 6 weeks apart
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
97
|
|
Overall Study
COMPLETED
|
46
|
87
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Normal Saline
Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
|
Artefill
n=97 Participants
Artefill: Administration of up to 2 study treatments administered 6 weeks apart
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
97 participants
n=7 Participants
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-treatmentPopulation: Full Analysis Population included only subjects that passed screening
Subject considered to be a "responder" if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment).
Outcome measures
| Measure |
Placebo
n=50 Participants
Normal Saline
Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
|
Artefill
n=97 Participants
Artefill: Administration of up to 2 study treatments administered 6 weeks apart
|
|---|---|---|
|
ASRS Responder Rate at 6 Months
|
32.4 percentage of participants
Interval 17.3 to 52.2
|
67.4 percentage of participants
Interval 51.3 to 80.2
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Artefill
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
Normal Saline
Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
|
Artefill
n=97 participants at risk
Artefill: Administration of up to 2 study treatments administered 6 weeks apart
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • 12 months post treatment
|
1.0%
1/97 • Number of events 1 • 12 months post treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • 12 months post treatment
|
1.0%
1/97 • Number of events 1 • 12 months post treatment
|
|
Infections and infestations
Meningitis
|
0.00%
0/50 • 12 months post treatment
|
1.0%
1/97 • Number of events 1 • 12 months post treatment
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.0%
1/50 • Number of events 1 • 12 months post treatment
|
0.00%
0/97 • 12 months post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer (recurrent)
|
2.0%
1/50 • Number of events 1 • 12 months post treatment
|
0.00%
0/97 • 12 months post treatment
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER