NCT01680497已完成不适用
Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
研究概览
简要总结
A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds
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
- •Male or female 18 years of age or older
- •Have 2 fully visible, approximately symmetrical nasolabial folds and has severity scores of 2 or 3 on the 5-point photographic nasolabial fold severity scale (range 0-4) for both nasolabial folds, as judged by the Investigator
- •Have a reasonable expectation for correction by injection via deep dermis, as described in the protocol
- •Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face (below the orbital rim) for the duration of the study
- •Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent prior to any study-related procedures being performed
- •Be in good health as in the opinion of the Investigator
排除标准
- •Has undergone cosmetic facial procedures (e.g., face lift or other surgeries) which may alter the appearance of the nasolabial fold area
- •Cosmetic injections in the lower two-thirds of the face (below the orbital rim), within 6 months prior to entry in the study, or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
- •Has undergone volumizing of the mid/lower face within 9 months prior to study entry
- •Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded poly-tetrafluoroethylene) anywhere in the lower face (below the orbital rim), or be planning to be implanted with any of these products at any time during the study
- •Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (an any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study
- •Be a pregnant female, lactating, or planning to become pregnant at any time during the study
- •Be a female of childbearing potential not using a reliable means of contraception
- •Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
- •Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)
- •Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease)
- •Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications)
- •Have a history of skin cancer
- •Suffer from porphyria
- •Have epilepsy, which is not controlled by anti-epilepsy therapy
- •Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes)
- •Have a history of treatment with interferon
- •Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day period
- •Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions
- •Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics
- •Have impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction
- •Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
研究组 & 干预措施
JUVÉDERM VOLIFT™
Experimental
All subjects receiving treatment with JUVÉDERM VOLIFT™.
干预措施: Crosslinked hyaluronic acid dermal filler (Device)
结局指标
主要结局
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
时间窗: Month 12
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
次要结局
- Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS(Day 0, Day 14, Month 1, Month 9)
- Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale(Day 14, Month 1, Month 9, Month 12)
- Investigator Assessment of Ease of Injection Use on a 10-Point Scale(Day 0, Day 14)
- Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale(Day 14, Month 1, Month 9, Month 12)
- Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale(Day 0, Day 14, Month 12, Month 12.5)
- Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS(Day 0, Day 14, Month 1, Month 9, Month 12)
研究者
研究点 (3)
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