Trial Outcomes & Findings for Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI (NCT NCT00891774)
NCT ID: NCT00891774
Last Updated: 2019-02-06
Results Overview
Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
COMPLETED
NA
172 participants
6 months post injection
2019-02-06
Participant Flow
Participant milestones
| Measure |
Device
Treatment with EVOLENCE®
|
|---|---|
|
Overall Study
STARTED
|
172
|
|
Overall Study
COMPLETED
|
158
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Device
Treatment with EVOLENCE®
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Illness (Self/Mother)
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
4
|
Baseline Characteristics
Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI
Baseline characteristics by cohort
| Measure |
Device
n=172 Participants
Treatment with EVOLENCE®
|
|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 10.28 • n=39 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
6 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
|
135 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=39 Participants
|
|
Region of Enrollment
North America · United States
|
172 Participants
n=39 Participants
|
|
Fitzpatrick Skin Tone
IV (Light Brown)
|
54 Participants
n=39 Participants
|
|
Fitzpatrick Skin Tone
V (Brown)
|
66 Participants
n=39 Participants
|
|
Fitzpatrick Skin Tone
VI (Dark Brown/Black)
|
52 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 6 months post injectionSafety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
Outcome measures
| Measure |
Device
n=172 Participants
Treatment with EVOLENCE®
|
|---|---|
|
Safety Endpoint
Success
|
155 Participants
|
|
Safety Endpoint
Keloid Formation
|
0 Participants
|
|
Safety Endpoint
Pigmentation Change
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1, 3 and 6 months post injectionPopulation: Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 3 and 6 months post injectionPopulation: Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 3 and 6 months post injectionPopulation: Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported.
Outcome measures
Outcome data not reported
Adverse Events
Device
Serious adverse events
| Measure |
Device
n=154 participants at risk；n=158 participants at risk
Treatment with EVOLENCE®
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.63%
1/158 • Number of events 1 • 6 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enlarging Multifibroid Uterus
|
0.63%
1/158 • Number of events 1 • 6 Months
|
|
Renal and urinary disorders
Bladder Failure
|
0.63%
1/158 • Number of events 1 • 6 Months
|
Other adverse events
| Measure |
Device
n=154 participants at risk；n=158 participants at risk
Treatment with EVOLENCE®
|
|---|---|
|
General disorders
Administration Site Conditions
|
100.0%
154/154 • 6 Months
|
|
Infections and infestations
Oral or Upper Respiratory Infections
|
7.8%
12/154 • 6 Months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.0%
17/154 • 6 Months
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
7.8%
12/154 • 6 Months
|
Additional Information
Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. The Institution will provide Sponsor with at least sixty (60) days for review of a manuscript, and if requested in writing, the Institution and Principal Investigators will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER