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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Keloid Formation at Site of Injection
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Elevess (Device)
结局指标
主要结局
Keloid Formation at Site of Injection
时间窗: 24 Weeks
Percentage of subjects with keloid formation at the site of injection at End of Study
Pigmentation Changes at Site of Injection
时间窗: 24 Weeks
Percentage of subjects with pigmentation changes at site of injection at End of Study
Keloid Formation at Site of Injection
时间窗: 2 Weeks
Percentage of Subjects with keloid formation at the site of injection
Keloid Formation at Site of Injection
时间窗: 6 Weeks
Percentage of Subjects with keloid formation at the site of injection
Keloid Formation at Site of Injection
时间窗: 12 Weeks
Percentage of Subjects with keloid formation at the site of injection
Pigmentation Changes at Site of Injection
时间窗: 2 Weeks
Percentage of Subjects with pigmentation changes at site of injection
Pigmentation Changes at Site of Injection
时间窗: 6 Weeks
Percentage of Subjects with pigmentation changes at site of injection
Pigmentation Changes at Site of Injection
时间窗: 12 Weeks
Percentage of Subjects with pigmentation changes at site of injection
次要结局
未报告次要终点