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

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ClinicalTrials.gov Identifier: NCT01559922
Recruitment Status : Completed
First Posted : March 21, 2012
Results First Posted : February 14, 2017
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
ethica Clinical Research Inc.
Information provided by (Responsible Party):
Suneva Medical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atrophic Acne Scar
Interventions Drug: Normal Saline
Device: Artefill
Enrollment 175
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 Details  
Arm/Group Title Placebo Artefill
Hide 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
Arm/Group Title Placebo Artefill Total
Hide 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 Number of Baseline Participants 50 97 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 97 participants 147 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
97
 100.0%
147
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 97 participants 147 participants
Female
30
  60.0%
60
  61.9%
90
  61.2%
Male
20
  40.0%
37
  38.1%
57
  38.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 97 participants 147 participants
American Indian or Alaska Native
0
   0.0%
2
   2.1%
2
   1.4%
Asian
4
   8.0%
4
   4.1%
8
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.0%
1
   0.7%
Black or African American
8
  16.0%
20
  20.6%
28
  19.0%
White
38
  76.0%
70
  72.2%
108
  73.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 97 participants 147 participants
Hispanic or Latino
13
  26.0%
20
  20.6%
33
  22.4%
Not Hispanic or Latino
37
  74.0%
77
  79.4%
114
  77.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 97 participants 147 participants
50 97 147
1.Primary Outcome
Title ASRS Responder Rate at 6 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population included only subjects that passed screening
Arm/Group Title Placebo Artefill
Hide 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
Overall Number of Participants Analyzed 50 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32.4
(17.3 to 52.2)
67.4
(51.3 to 80.2)
Time Frame 12 months post treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Artefill
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Artefill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      3/97 (3.09%)    
Hepatobiliary disorders     
Cholecystitis acute  1  1/50 (2.00%)  1 0/97 (0.00%)  0
Infections and infestations     
Meningitis  1  0/50 (0.00%)  0 1/97 (1.03%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/50 (0.00%)  0 1/97 (1.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer (recurrent)  1  1/50 (2.00%)  1 0/97 (0.00%)  0
Psychiatric disorders     
Depression  1  0/50 (0.00%)  0 1/97 (1.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Artefill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/97 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Suneva Medical,Inc.
Organization: Suneva Medical, Inc.
EMail: Acne.ScarInfo@sunevamedical.com
Layout table for additonal information
Responsible Party: Suneva Medical, Inc.
ClinicalTrials.gov Identifier: NCT01559922     History of Changes
Other Study ID Numbers: SUN-11-001
First Submitted: March 15, 2012
First Posted: March 21, 2012
Results First Submitted: October 2, 2014
Results First Posted: February 14, 2017
Last Update Posted: November 1, 2019