Safety Study of Cosmetic Tissue Augmentation in People of Color

Completed · Not applicable

Conditions studied: Wrinkles

In brief

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)

Key facts

Study ID

NCT01147172

Run by

Anika Therapeutics, Inc.

People needed

100

Starts

2009-03-01

Expected to finish

2010-08-01

Last updated by the study team

2017-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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