Trial Outcomes & Findings for The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area (NCT NCT02642627)
NCT ID: NCT02642627
Last Updated: 2020-04-06
Results Overview
A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen. Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow). Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow). Moderate: More than half of the depressions are apparent with direct lighting (deep). Severe: All or almost all the lesions can be seen with direct lighting (deep)
COMPLETED
NA
42 participants
Month 1, 4 and 7
2020-04-06
Participant Flow
Participant milestones
| Measure |
Bellafill Injections
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
Bellafill
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area
Baseline characteristics by cohort
| Measure |
Bellafill Injections
n=42 Participants
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
Bellafill
|
|---|---|
|
Age, Continuous
|
43.38 years
STANDARD_DEVIATION 12.79 • n=39 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Month 1, 4 and 7Population: The overall number of participants was all subjects enrolled in the clinical trial. The number analyzed includes the number of participants with available data for each time point.
A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen. Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow). Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow). Moderate: More than half of the depressions are apparent with direct lighting (deep). Severe: All or almost all the lesions can be seen with direct lighting (deep)
Outcome measures
| Measure |
Bellafill Injections
n=42 Participants
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
Bellafill
|
|---|---|
|
Change on the Acne Scar Assessment Scale (ASAS)
Month 1
|
3.33 units on a scale
Standard Deviation 0.78
|
|
Change on the Acne Scar Assessment Scale (ASAS)
Month 4
|
2.19 units on a scale
Standard Deviation 0.65
|
|
Change on the Acne Scar Assessment Scale (ASAS)
Month 7
|
2.20 units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: month 7Throughout the course of the study, all AEs will be monitored and reported through the CRF. All AEs occurring after study device administration were followed until the event has resolved or stabilized or until follow-up was no longer possible.
Outcome measures
| Measure |
Bellafill Injections
n=42 Participants
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
Bellafill
|
|---|---|
|
Adverse Events
All Adverse Events
|
6 adverse events
|
|
Adverse Events
Treatment Related Adverse Events
|
2 adverse events
|
Adverse Events
Bellafill Injections
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bellafill Injections
n=42 participants at risk
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
4.8%
2/42 • Number of events 2 • 7 months
|
|
Skin and subcutaneous tissue disorders
Injection Site hemorrhage (Skin Test)
|
2.4%
1/42 • Number of events 1 • 7 months
|
|
General disorders
Injection Site Pain
|
4.8%
2/42 • Number of events 2 • 7 months
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • Number of events 1 • 7 months
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
2.4%
1/42 • Number of events 1 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place