NCT00891774

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non Therapeutic Body Modification

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-12-31
• Primary completion: 2009-11-30
• Completion: 2009-11-30
• First posted: 2009-05-01
• Last updated: 2019-02-06
• Results posted: 2011-05-13

Locations

11 sites across 1 country: United States