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Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00891774
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : May 13, 2011
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Therapeutic Body Modification
Intervention Device: EVOLENCE®
Enrollment 172
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Device
Hide Arm/Group Description Treatment with EVOLENCE®
Period Title: Overall Study
Started 172
Completed 158
Not Completed 14
Reason Not Completed
Lost to Follow-up             5
Illness (Self/Mother)             3
Withdrawal by Subject             2
Protocol Violation             4
Arm/Group Title Device
Hide Arm/Group Description Treatment with EVOLENCE®
Overall Number of Baseline Participants 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants
51.4  (10.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Female
150
  87.2%
Male
22
  12.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Hispanic or Latino
18
  10.5%
Not Hispanic or Latino
154
  89.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
American Indian or Alaska Native
4
   2.3%
Asian
6
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
135
  78.5%
White
17
   9.9%
More than one race
0
   0.0%
Unknown or Not Reported
10
   5.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
North America Number Analyzed 172 participants
United States
172
 100.0%
Fitzpatrick Skin Tone  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
IV (Light Brown)
54
  31.4%
V (Brown)
66
  38.4%
VI (Dark Brown/Black)
52
  30.2%
1.Primary Outcome
Title Safety Endpoint
Hide Description Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
Time Frame 6 months post injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device
Hide Arm/Group Description:
Treatment with EVOLENCE®
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Participants
Success 155
Keloid Formation 0
Pigmentation Change 3
2.Secondary Outcome
Title Reduction in Wrinkle Severity Score
Hide Description [Not Specified]
Time Frame Baseline, 1, 3 and 6 months post injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Device
Hide Arm/Group Description:
Treatment with EVOLENCE®
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Investigator’s Satisfaction of the Overall Treatment
Hide Description [Not Specified]
Time Frame 1, 3 and 6 months post injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Device
Hide Arm/Group Description:
Treatment with EVOLENCE®
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Subject’s Satisfaction of the Overall Treatment
Hide Description [Not Specified]
Time Frame 1, 3 and 6 months post injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Device
Hide Arm/Group Description:
Treatment with EVOLENCE®
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Device
Hide Arm/Group Description Treatment with EVOLENCE®
All-Cause Mortality
Device
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Device
Affected / at Risk (%) # Events
Total   3/158 (1.90%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Non-small cell lung cancer   1/158 (0.63%)  1
Enlarging Multifibroid Uterus   1/158 (0.63%)  1
Renal and urinary disorders   
Bladder Failure   1/158 (0.63%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Device
Affected / at Risk (%) # Events
Total   154/154 (100.00%)    
General disorders   
Administration Site Conditions   154/154 (100.00%) 
Infections and infestations   
Oral or Upper Respiratory Infections   12/154 (7.79%) 
Skin and subcutaneous tissue disorders   
Erythema   17/154 (11.04%) 
Skin Hyperpigmentation   12/154 (7.79%) 
Indicates events were collected by systematic assessment
Sponsor discontinued US marketing of product; program terminated. No analysis performed on Secondary Measures. Sincere efforts were made to obtain secondary measure data; there is no longer access to these data and therefore no data can be reported.
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 928-277-0715
EMail: jhauze@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00891774     History of Changes
Obsolete Identifiers: NCT00871988
Other Study ID Numbers: DP101 US-04
First Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: April 15, 2011
Results First Posted: May 13, 2011
Last Update Posted: February 6, 2019