Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI
This study has been completed.
Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
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
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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
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 |
| 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 May 23, 2013