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

Johnson & Johnson Consumer and Personal Products Worldwide172 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

172

Conditions

Non Therapeutic Body Modification

Interventions

EVOLENCE®DEVICE

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (11)

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 D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months post injection

Secondary Outcomes

Reduction in Wrinkle Severity Score

Time frame: Baseline, 1, 3 and 6 months post injection

Investigator's Satisfaction of the Overall Treatment

Time frame: 1, 3 and 6 months post injection

Subject's Satisfaction of the Overall Treatment

Time frame: 1, 3 and 6 months post injection

Data from ClinicalTrials.gov

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