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A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars

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ClinicalTrials.gov Identifier: NCT02643628
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : October 28, 2019
Last Update Posted : October 28, 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: None (Open Label);   Primary Purpose: Treatment
Condition Atrophic Acne Scars
Interventions Procedure: Microneedling
Device: Microneedling followed by Bellafill treatment
Enrollment 45
Recruitment Details  
Pre-assignment Details 55 subjects screened with 45 meeting eligibility criteria and enrolled. One subject discontinued by investigator. 44 subjects randomized 23 to Microneedling + Bellafill and 21 to Microneedling alone.
Arm/Group Title Microneedling Only Microneedling Followed by Bellafill Treatment
Hide Arm/Group Description All subjects eligible scars within the treatment areas on each side of the face will receive microneedling treatment. At Week 12 subjects randomized to no further treatment.

All Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

Period Title: Overall Study
Started 21 23
Completed 20 17
Not Completed 1 6
Reason Not Completed
Lost to Follow-up             1             4
Withdrawal by Subject             0             1
Relocated out of state             0             1
Arm/Group Title Microneedling Only Microneedling Followed by Bellafill Treatment Total
Hide Arm/Group Description All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. Subjects randomized at week 12 to no further treatment.

Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

Total of all reporting groups
Overall Number of Baseline Participants 21 23 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
23
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 23 participants 44 participants
36.50  (10.68) 40.67  (13.12) 38.68  (12.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Female
11
  52.4%
18
  78.3%
29
  65.9%
Male
10
  47.6%
5
  21.7%
15
  34.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Hispanic or Latino
7
  33.3%
3
  13.0%
10
  22.7%
Not Hispanic or Latino
14
  66.7%
20
  87.0%
34
  77.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   9.5%
2
   8.7%
4
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   8.7%
2
   4.5%
Black or African American
1
   4.8%
1
   4.3%
2
   4.5%
White
17
  81.0%
17
  73.9%
34
  77.3%
More than one race
1
   4.8%
1
   4.3%
2
   4.5%
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 21 participants 23 participants 44 participants
21 23 44
1.Primary Outcome
Title Acne Scar Assessment Scale (ASAS)
Hide Description Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe
Time Frame 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects
Arm/Group Title Microneedling Followed by Bellafill Treatment Microneedling Only
Hide Arm/Group Description:

Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.

Microneedling

Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.65  (0.75) 3.71  (0.75)
2.Primary Outcome
Title Physician Global Aesthetic Improvement Scale (PGAIS)
Hide Description The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
Time Frame From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm
Hide Outcome Measure Data
Hide Analysis Population Description
There were 21 subjects in the microneedling arm however data only available for 19 subjects
Arm/Group Title Microneedling Only Microneedling Followed by Bellafill Treatment
Hide Arm/Group Description:

All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.

Microneedling

Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

Overall Number of Participants Analyzed 19 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (0.62) 0.35  (0.49)
3.Primary Outcome
Title Subject Global Aesthetic Improvement Scale (SGAIS)
Hide Description The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
Time Frame From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm
Hide Outcome Measure Data
Hide Analysis Population Description
There were 21 subjects in the microneedling arm however data only available for 19 subjects
Arm/Group Title Microneedling Only Microneedling Followed by Bellafill Treatment
Hide Arm/Group Description:

All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.

Microneedling

Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

Overall Number of Participants Analyzed 19 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (0.62) 0.18  (0.39)
4.Primary Outcome
Title Quality of Life Impact Scar (QOLIS)
Hide Description Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7.
Time Frame 6-months for the Treatment arm and 3 months for the Microneedling only arm
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microneedling Only Microneedling Followed by Bellafill Treatment
Hide Arm/Group Description:

All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.

Microneedling

Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.90  (1.45) 2.47  (1.42)
5.Primary Outcome
Title Number of Subjects With Adverse Events
Hide Description [Not Specified]
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microneedling Followed by Bellafill Treatment Microneedling Only
Hide Arm/Group Description:

Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.

Microneedling

Overall Number of Participants Analyzed 23 21
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.7%
1
   4.8%
Time Frame six (6) months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Microneedling Followed by Bellafill Treatment Microneedling Only
Hide Arm/Group Description

Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.

Microneedling followed by Bellafill treatment

All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.

Microneedling

All-Cause Mortality
Microneedling Followed by Bellafill Treatment Microneedling Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Microneedling Followed by Bellafill Treatment Microneedling Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Microneedling Followed by Bellafill Treatment Microneedling Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/23 (8.70%)      1/21 (4.76%)    
Immune system disorders     
slight cold  [1]  1/23 (4.35%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Peripheral edema of the foot   1/23 (4.35%)  1 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
Treatment Site Dermatitis  [2]  0/23 (0.00%)  0 1/21 (4.76%)  1
Indicates events were collected by systematic assessment
[1]
Subject had a slight cold
[2]
Treatment Site Dermatitis was attributed to the microneedling procedure.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Affairs
Organization: Suneva Medical
Phone: 858-324-6268
EMail: alehman@sunevamedical.com
Layout table for additonal information
Responsible Party: Suneva Medical, Inc.
ClinicalTrials.gov Identifier: NCT02643628     History of Changes
Other Study ID Numbers: SUN-1503
First Submitted: December 29, 2015
First Posted: December 31, 2015
Results First Submitted: September 24, 2019
Results First Posted: October 28, 2019
Last Update Posted: October 28, 2019