Trial Outcomes & Findings for A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars (NCT NCT02643628)
NCT ID: NCT02643628
Last Updated: 2019-10-28
Results Overview
• 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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
6 months post-injection for Bellafill arm. 3 months Microneedling alone arm
Results posted on
2019-10-28
Participant Flow
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.
Participant milestones
| Measure |
Microneedling Only
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.
|
Microneedling Followed by Bellafill 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
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Microneedling Only
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.
|
Microneedling Followed by Bellafill 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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Relocated out of state
|
0
|
1
|
Baseline Characteristics
A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars
Baseline characteristics by cohort
| Measure |
Microneedling Only
n=21 Participants
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.
|
Microneedling Followed by Bellafill Treatment
n=23 Participants
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
n=44 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
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.50 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
40.67 years
STANDARD_DEVIATION 13.12 • n=7 Participants
|
38.68 years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-injection for Bellafill arm. 3 months Microneedling alone armPopulation: All subjects
• 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
Outcome measures
| Measure |
Microneedling Followed by Bellafill Treatment
n=17 Participants
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
|
Microneedling Only
n=19 Participants
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
|
|---|---|---|
|
Acne Scar Assessment Scale (ASAS)
|
2.65 units on a scale
Standard Deviation 0.75
|
3.71 units on a scale
Standard Deviation 0.75
|
PRIMARY outcome
Timeframe: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only armPopulation: There were 21 subjects in the microneedling arm however data only available for 19 subjects
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
Outcome measures
| Measure |
Microneedling Followed by Bellafill Treatment
n=19 Participants
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
|
Microneedling Only
n=17 Participants
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
|
|---|---|---|
|
Physician Global Aesthetic Improvement Scale (PGAIS)
|
0.05 units on a scale
Standard Deviation 0.62
|
0.35 units on a scale
Standard Deviation 0.49
|
PRIMARY outcome
Timeframe: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only armPopulation: There were 21 subjects in the microneedling arm however data only available for 19 subjects
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
Outcome measures
| Measure |
Microneedling Followed by Bellafill Treatment
n=19 Participants
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
|
Microneedling Only
n=17 Participants
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
|
|---|---|---|
|
Subject Global Aesthetic Improvement Scale (SGAIS)
|
0.05 units on a scale
Standard Deviation 0.62
|
0.18 units on a scale
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: 6-months for the Treatment arm and 3 months for the Microneedling only armQuality 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.
Outcome measures
| Measure |
Microneedling Followed by Bellafill Treatment
n=20 Participants
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
|
Microneedling Only
n=17 Participants
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
|
|---|---|---|
|
Quality of Life Impact Scar (QOLIS)
|
3.90 units on a scale
Standard Deviation 1.45
|
2.47 units on a scale
Standard Deviation 1.42
|
PRIMARY outcome
Timeframe: 6-monthsOutcome measures
| Measure |
Microneedling Followed by Bellafill Treatment
n=23 Participants
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
|
Microneedling Only
n=21 Participants
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
|
|---|---|---|
|
Number of Subjects With Adverse Events
|
2 Participants
|
1 Participants
|
Adverse Events
Microneedling Followed by Bellafill Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Microneedling Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Microneedling Followed by Bellafill Treatment
n=23 participants at risk
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
|
Microneedling Only
n=21 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Treatment Site Dermatitis
|
0.00%
0/23 • six (6) months
|
4.8%
1/21 • Number of events 1 • six (6) months
|
|
Musculoskeletal and connective tissue disorders
Peripheral edema of the foot
|
4.3%
1/23 • Number of events 1 • six (6) months
|
0.00%
0/21 • six (6) months
|
|
Immune system disorders
slight cold
|
4.3%
1/23 • Number of events 1 • six (6) months
|
0.00%
0/21 • six (6) months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place