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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00891774
First received: April 30, 2009
Last updated: October 4, 2011
Last verified: October 2011

April 30, 2009
October 4, 2011
December 2008
November 2009   (final data collection date for primary outcome measure)
Safety Endpoint [ Time Frame: 6 months post injection ] [ Designated as safety issue: No ]
Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
Local and systemic adverse events, including pigmentation changes and keloid formation [ Time Frame: Baseline, 1, 3 and 6 months post injection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00891774 on ClinicalTrials.gov Archive Site
  • Reduction in Wrinkle Severity Score [ Time Frame: Baseline, 1, 3 and 6 months post injection ] [ Designated as safety issue: No ]
  • Investigator's Satisfaction of the Overall Treatment [ Time Frame: 1, 3 and 6 months post injection ] [ Designated as safety issue: No ]
  • Subject's Satisfaction of the Overall Treatment [ Time Frame: 1, 3 and 6 months post injection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI
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

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Therapeutic Body Modification
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
Experimental: Device
Treatment with EVOLENCE®
Intervention: Device: EVOLENCE®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00891774
DP101 US-04
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Director: David Shoshani, MD Colbar/OrthoDermatologics
Johnson & Johnson Consumer and Personal Products Worldwide
October 2011

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