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
  Purpose

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.


Condition Intervention Phase
Non Therapeutic Body Modification
Device: EVOLENCE®
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 172
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device
Treatment with EVOLENCE®
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891774

Locations
United States, California
The Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, United States, 90036
Desert Dermatology Medical Associates
Rancho Mirage, California, United States, 92270
United States, District of Columbia
Center for Dermatology and Dermatologic Surgery
Washington, District of Columbia, United States, 20037
United States, Georgia
Atlanta Dermatology Vein & Research Center
Alpharetta, Georgia, United States, 30022
United States, Illinois
Denova Research
Chicago, Illinois, United States, 60611
DuPage Medical Group Clinical Research
Naperville, Illinois, United States, 60563
United States, Maryland
Callender Center for Clinical Research
Mitchellville, Maryland, United States, 20721
United States, Michigan
The Boyd Gillard Institute of Aesthetic & Dermatology Surgery
Ypsilanti, Michigan, United States, 48197
United States, New Jersey
Image Dermatology
Montclair, New Jersey, United States, 07042
United States, Pennsylvania
Susan Taylor
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Tennessee Clinical Research
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: David Shoshani, MD Colbar/OrthoDermatologics
  More Information

No publications provided

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
Study First Received: April 30, 2009
Results First Received: April 15, 2011
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014