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
1 other identifier
interventional
172
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2008
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2009
CompletedFirst Posted
Study publicly available on registry
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2009
CompletedResults Posted
Study results publicly available
May 13, 2011
CompletedFebruary 6, 2019
January 1, 2019
11 months
April 30, 2009
April 15, 2011
January 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (1)
Device
EXPERIMENTALTreatment with EVOLENCE®
Interventions
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
Eligibility Criteria
You may qualify if:
- \>18 years of age
- moderate to deep wrinkle in the Naso-Labial fold
- Fitzpatrick Skin Type IV, V or VI
You may not qualify if:
- Pregnant or nursing females
- Hx of allergies to related products
- history of keloids, active skin disease, or previous augmentation of the treatment area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, 90036, United States
Desert Dermatology Medical Associates
Rancho Mirage, California, 92270, United States
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, 20037, United States
Atlanta Dermatology Vein & Research Center
Alpharetta, Georgia, 30022, United States
Denova Research
Chicago, Illinois, 60611, United States
DuPage Medical Group Clinical Research
Naperville, Illinois, 60563, United States
Callender Center for Clinical Research
Mitchellville, Maryland, 20721, United States
The Boyd Gillard Institute of Aesthetic & Dermatology Surgery
Ypsilanti, Michigan, 48197, United States
Image Dermatology
Montclair, New Jersey, 07042, United States
Susan Taylor
Philadelphia, Pennsylvania, 19107, United States
Tennessee Clinical Research
Nashville, Tennessee, 37215, United States
Limitations and Caveats
Sponsor discontinued US marketing of product; program terminated. No analysis performed on Secondary Measures. Sincere efforts were made to obtain secondary measure data; there is no longer access to these data and therefore no data can be reported.
Results Point of Contact
- Title
- Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
- Organization
- Johnson & Johnson Consumer and Personal Products Worldwide
Study Officials
- STUDY DIRECTOR
David Shoshani, MD
Colbar/OrthoDermatologics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2009
First Posted
May 1, 2009
Study Start
December 31, 2008
Primary Completion
November 30, 2009
Study Completion
November 30, 2009
Last Updated
February 6, 2019
Results First Posted
May 13, 2011
Record last verified: 2019-01