Safety Study of Cosmetic Tissue Augmentation in People of Color

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Elevess	Elevess	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

Primary Outcome Measures

Name	Time	Method
Keloid Formation at Site of Injection	24 Weeks	Percentage of subjects with keloid formation at the site of injection at End of Study
Pigmentation Changes at Site of Injection	24 Weeks	Percentage of subjects with pigmentation changes at site of injection at End of Study

Secondary Outcome Measures

Name	Time	Method

Locations (9): Vitiligo and Pigmentation Inst of Southern California
🇺🇸
Los Angeles, California, United States
International Dermatology Research
🇺🇸
Miami, Florida, United States
Skin Care Research, Inc.
🇺🇸
Boca Raton, Florida, United States
Dermatology Research Institute, LLC
🇺🇸
Coral Gables, Florida, United States
William Coleman, MD
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Metairie, Louisiana, United States
St Luke's Roosevelt
🇺🇸
New York, New York, United States
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
Tenneesee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Derm Research, Inc.
🇺🇸
Austin, Texas, United States