CTRI/2017/09/009848已完成Unknown
An Prospective,open label,multicentric, single-arm, non-comparative post marketing clinical study to evaluate effectiveness and safety of Restylane® Lidocaine in subjects undergoing treatment for facial wrinkles and lip augmentation and Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds and volume loss
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of Restylane® Lidocaine in subjects undergoing treatment for facial wrinkles and lip augmentation and Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds and volume loss
研究概览
简要总结
AnProspective,open label,multicentric, single-arm, non-comparative post marketingclinical study to evaluate effectiveness and safety of Restylane® Lidocaine insubjects undergoing treatment for facial wrinkles and lip augmentation andRestylane® Perlane Lidocaine in subjects undergoing treatment for facial foldsand volume loss. Total 100 subjects would be enrolled in the study and study consists of 3 visits at Day-0 , Day- 14 and Day- 30. The efficacy assessment will be done through- Wrinkle Severity Rating Scale (WSRS), GlobalAesthetic Improvement Scale (GAIS), Lip Fullness Grading Scale (LFGS), Medicis Midface Volume Scale.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female of age between 18 to 55 years 2.Subjects intending to undergo facial filler treatment for either volume loss or contouring in midface as per investigator’s judgment/opinion 3.Subjects requiring treatment for lip augmentation or rejuvenation.
- •4.Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period 5.Female subjects of childbearing potential who agree to use medically acceptable contraception (e.g., condom, oral contraceptives continuing from at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial 6.Non-pregnant, non-breast feeding females 7.Subjects who voluntarily decided to participate in the study and willing to give the informed consent 8.Able to understand and follow instructions and participate the entire period of the clinical trial.
排除标准
- •1.Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; 2.Subjects with traumatic scars or ongoing active skin disease in the area to be treated 3.Permanent implant or filler, including fat injection placed in the area to be treated 4.Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion 5.Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steroidal anti-inflammatory drugs, acetylsalicylic acid, omega 3 and Vitamin E) within 2 weeks prior to treatment 6.Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (Inhaled corticosteroids are allowed) 7.Active or chronic skin disease, inflammation or related conditions (skin eruptions such as cysts, pimples, rashes, or hives), near or on the Nasolabial Folds 8.Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry 9.History of chronic sinusitis or rhinitis (only applicable for subjects injected over the nose).
- •10.Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skin boosters in the facial area within 12 months before treatment.
- •11.Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
- •12.Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
- •13.Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
- •14.Patients with bleeding disorders 15.Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
结局指标
主要结局
To evaluate the safety and tolerability of Restylane® Lidocaine in subjects undergoing treatment for facial wrinkles and lip augmentation and Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds and volume loss
时间窗: Visit I (Day 0), Visit II (Day 14), Visit III (Day 30)
次要结局
- To evaluate the effectiveness of Restylane® Lidocaine in subjects undergoing treatment for facial wrinkles and lip augmentation and Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds and volume loss(Visit I (Day 0), Visit II (Day 14), Visit III (Day 30))
研究者
研究点 (2)
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