Status:
COMPLETED
Safety Study of Cosmetic Tissue Augmentation in People of Color
Lead Sponsor:
Anika Therapeutics, Inc.
Conditions:
Wrinkles
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01147172
Start Date
March 1 2009
End Date
August 1 2010
Last Update
October 17 2017
Active Locations (9)
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1
Vitiligo and Pigmentation Inst of Southern California
Los Angeles, California, United States, 90036
2
Skin Care Research, Inc.
Boca Raton, Florida, United States, 33486
3
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146
4
International Dermatology Research
Miami, Florida, United States, 33144