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.

Study Overview

• Status: Completed
• Conditions: Non Therapeutic Body Modification
• Intervention / Treatment: Device: EVOLENCE®

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
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • The Vitiligo and Pigmentation Institute of Southern California
    • Rancho Mirage, California, United States, 92270
      • Desert Dermatology Medical Associates
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Center for Dermatology and Dermatologic Surgery
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology Vein & Research Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
    • Naperville, Illinois, United States, 60563
      • DuPage Medical Group Clinical Research
  • Maryland
    • Mitchellville, Maryland, United States, 20721
      • Callender Center for Clinical Research
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • The Boyd Gillard Institute of Aesthetic & Dermatology Surgery
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Image Dermatology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Susan Taylor
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Facial augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation	6 months post injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in Wrinkle Severity Score	Baseline, 1, 3 and 6 months post injection
Investigator's Satisfaction of the Overall Treatment	1, 3 and 6 months post injection
Subject's Satisfaction of the Overall Treatment	1, 3 and 6 months post injection

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: David Shoshani, MD, Colbar/OrthoDermatologics

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2008
• Primary Completion (Actual): November 30, 2009
• Study Completion (Actual): November 30, 2009

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): May 1, 2009

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DP101 US-04