CTRI/2017/09/009848已完成4 期
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
- 4 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
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 investigatorâ??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).
研究者
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