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

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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

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 1, 2009
Results First Submitted Date  ICMJE April 15, 2011
Results First Posted Date  ICMJE May 13, 2011
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE December 31, 2008
Actual Primary Completion Date November 30, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Safety Endpoint [ Time Frame: 6 months post injection ]
Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Local and systemic adverse events, including pigmentation changes and keloid formation [ Time Frame: Baseline, 1, 3 and 6 months post injection ]
Change History Complete list of historical versions of study NCT00891774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
  • Reduction in Wrinkle Severity Score [ Time Frame: Baseline, 1, 3 and 6 months post injection ]
  • Investigator's Satisfaction of the Overall Treatment [ Time Frame: 1, 3 and 6 months post injection ]
  • Subject's Satisfaction of the Overall Treatment [ Time Frame: 1, 3 and 6 months post injection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI
Official Title  ICMJE An Open-label, Multi-Center, Prospective, Post Market Study to Assess the Safety and Effectiveness of EVOLENCE® in Facial Augmentation of Subjects With Fitzpatrick Skin Color Types IV, V, and VI
Brief Summary Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be observed for 6 months to establish safety of the product as it relates to scarring and changes in skin pigment, and long term effectiveness.
Detailed Description

This is an open-label, multi-center, prospective, postmarket study to assess the safety and effectiveness of EVOLENCE® (DP101) in Subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of bilateral facial wrinkles and folds of the nasolabial area.

The study will enroll and treat a total of 165 subjects with Fitzpatrick Skin Color Types IV, V and VI who have clinical evidence of moderate to deep bilateral wrinkles in the nasolabial area.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Therapeutic Body Modification
Intervention  ICMJE Device: EVOLENCE®
Single injection of material into the mid-dermis of the wrinkle - Second 'touch-up' injection is permitted approximately 14-Days later if needed to achieve satisfactory results
Other Name: Facial augmentation
Study Arms  ICMJE Experimental: Device
Treatment with EVOLENCE®
Intervention: Device: EVOLENCE®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
172
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
166
Actual Study Completion Date  ICMJE November 30, 2009
Actual Primary Completion Date November 30, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >18 years of age
  • moderate to deep wrinkle in the Naso-Labial fold
  • Fitzpatrick Skin Type IV, V or VI

Exclusion Criteria:

  • Pregnant or nursing females
  • Hx of allergies to related products
  • history of keloids, active skin disease, or previous augmentation of the treatment area
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891774
Other Study ID Numbers  ICMJE DP101 US-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide
Study Sponsor  ICMJE Johnson & Johnson Consumer and Personal Products Worldwide
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Shoshani, MD Colbar/OrthoDermatologics
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP