Safety Study of Cosmetic Tissue Augmentation in People of Color

Study Overview
=================
Brief Summary
-----------------
Elevess is intended for all skin types. However, further study of all soft tissue fillers is needed in people of color because of the increasing use of cosmetic dermal filler products. This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence and severity of keloid formation and pigmentation changes, and other potential adverse events in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial fold (NLF) treatment with Elevess. 1. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns, (deeply pigmented dark brown to black skin;Black)

Detailed Description
-----------------
This study is designed to be an open-label, longitudinal, uncontrolled study in a minimum of 100 subjects with Fitzpatrick scale skin type of IV, V or VI at 10 or more U.S. centers who have elected to undergo NLF treatment with intradermal (deep dermal) injection of Elevess. Subjects will be followed for a minimum of 24 weeks with visit assessments at 2, 6, 12 and 24 weeks after the last injection. Safety: Primary Safety Endpoint assessments will be: 1) keloid formation at the site of injection at 2, 6, 12 and 24 weeks, 2) pigmentation changes at the site of injection compared to adjacent skin at 2, 6, 12 and 24 weeks, and 3) overall adverse events. A subject diary will also be collected. Effectiveness: No formal effectiveness evaluation will be performed.

Official Title
-----------------
A Post Approval, Multicenter, Open-Label, Longitudinal, Uncontrolled Safety Study of Cosmetic Tissue Augmentation Product (ELEVESS™) in the Treatment of Nasolabial Folds in People of Color

Conditions
-----------------
Wrinkles

Intervention / Treatment
-----------------
* Device: Elevess


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick skin type of IV, V or VI. Bilateral nasolabial folds which, in the investigator's judgment, can be corrected with Elevess. Age greater or equal to 18 years. Exclusion Criteria: Fitzpatrick skin type of I, II or III. Subject has severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies. Subject has allergies to the components of Elevess: hyaluronic acid, lidocaine, sodium metabisulfite or gram positive bacterial proteins. Subject has a history of severe keloids and/or hypertrophic scars. Subject has ever received any soft tissue augmentation in any area of the face and subject is unwilling to forgo all other soft tissue augmentation for the duration of the study. Subject has received any aesthetic or dermatologic treatments or procedures in any area of the face in the previous 6 months and subject is unwilling to forgo such treatments or procedures for the duration of the study. Subject has active facial acne lesions, severe acne scarring or pigmentation disorders at the injection site that might affect clinical assessment of the nasolabial folds. Subject has ever received an injection or implant of silicone in any area of the face. Subject has received immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months. Subject has a history of a connective tissue disease. Subject is positive for HIV/AIDS or hepatitis C. Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elevess<br>Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite | Device: Elevess<br>* Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keloid Formation at Site of Injection | Percentage of Subjects with keloid formation at the site of injection | 2 Weeks | 
| Keloid Formation at Site of Injection | Percentage of Subjects with keloid formation at the site of injection | 6 Weeks | 
| Keloid Formation at Site of Injection | Percentage of Subjects with keloid formation at the site of injection | 12 Weeks | 
| Keloid Formation at Site of Injection | Percentage of subjects with keloid formation at the site of injection at End of Study | 24 Weeks | 
| Pigmentation Changes at Site of Injection | Percentage of Subjects with pigmentation changes at site of injection | 2 Weeks | 
| Pigmentation Changes at Site of Injection | Percentage of Subjects with pigmentation changes at site of injection | 6 Weeks | 
| Pigmentation Changes at Site of Injection | Percentage of Subjects with pigmentation changes at site of injection | 12 Weeks | 
| Pigmentation Changes at Site of Injection | Percentage of subjects with pigmentation changes at site of injection at End of Study | 24 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasolabial Folds, Cosmetic, Injectable Dermal Filler, Hyaluronic Acid with Lidocaine