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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 : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

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.

Condition or disease Intervention/treatment Phase
Non Therapeutic Body Modification Device: EVOLENCE® Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Reduction in Wrinkle Severity Score [ Time Frame: Baseline, 1, 3 and 6 months post injection ]
  2. Investigator's Satisfaction of the Overall Treatment [ Time Frame: 1, 3 and 6 months post injection ]
  3. Subject's Satisfaction of the Overall Treatment [ Time Frame: 1, 3 and 6 months post injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 Posted: May 1, 2009    Key Record Dates
Results First Posted: May 13, 2011
Last Update Posted: October 7, 2011
Last Verified: October 2011