Safety Study of Cosmetic Tissue Augmentation in People of Color
| Status: | Completed |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/19/2017 |
| Start Date: | March 2009 |
| End Date: | August 2010 |
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
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)
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)
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.
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.
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
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5670 Wilshire Boulevard
Los Angeles, California 90036
Los Angeles, California 90036
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