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

Not Applicable

Completed

• Conditions: Non Therapeutic Body Modification
• Interventions: Device: EVOLENCE®

• Registration Number: NCT00891774
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-12-31
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2009-11-30
• Study Completion: 2009-11-30
• Results First Submitted: 2011-04-15
• Results First Submitted QC: 2011-04-15
• Results First Posted: 2011-05-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device	EVOLENCE®	Treatment with EVOLENCE®

Primary Outcome Measures

Name	Time	Method
Safety Endpoint	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

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

Trial Locations

Locations (11)

Susan Taylor; 🇺🇸 Philadelphia, Pennsylvania, United States

Atlanta Dermatology Vein & Research Center; 🇺🇸 Alpharetta, Georgia, United States

Image Dermatology; 🇺🇸 Montclair, New Jersey, United States

The Boyd Gillard Institute of Aesthetic & Dermatology Surgery; 🇺🇸 Ypsilanti, Michigan, United States

Callender Center for Clinical Research; 🇺🇸 Mitchellville, Maryland, United States

Denova Research; 🇺🇸 Chicago, Illinois, United States

Tennessee Clinical Research; 🇺🇸 Nashville, Tennessee, United States

The Vitiligo and Pigmentation Institute of Southern California; 🇺🇸 Los Angeles, California, United States

Desert Dermatology Medical Associates; 🇺🇸 Rancho Mirage, California, United States

Center for Dermatology and Dermatologic Surgery; 🇺🇸 Washington, District of Columbia, United States

DuPage Medical Group Clinical Research; 🇺🇸 Naperville, Illinois, United States