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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non Therapeutic Body Modification

Intervention / Treatment
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* Device: EVOLENCE®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Treatment with EVOLENCE® | Device: EVOLENCE®<br>* 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<br>* Other names: Facial augmentation;|

What is the study measuring?
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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 | Measure Description | 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 |