An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure/Dysport Alone or Restylane/Emervel Filler Alone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
研究概览
简要总结
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Obvious facial sagging (major loss of facial fat/volume).
- •Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.
- •Heavily scarred or sun-damaged facial skin.
- •Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated.
- •Cancerous or pre-cancerous lesions in the areas to be treated.
- •Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months.
- •Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months.
- •Any aesthetic surgery of the face.
- •Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face.
- •History of severe keloids and/or hypertrophic scars.
- •Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration.
- •Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics.
- •History of autoimmune diseases.
- •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 affect the general condition or may require frequent medical treatment).
- •Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
- •Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.
- •Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.
研究组 & 干预措施
Azzalure/Dysport as single treatment
Azzalure/Dysport as single treatment at initial treatment
干预措施: Azzalure or Dysport (Drug)
Azzalure/Dysport as single treatment
Azzalure/Dysport as single treatment at initial treatment
干预措施: Restylane or Emervel filler (Device)
Azzalure/Dysport as single treatment
Azzalure/Dysport as single treatment at initial treatment
干预措施: Restylane Skinbooster (Device)
Filler as single treatment
Filler as single treatment at initial treatment
干预措施: Azzalure or Dysport (Drug)
Filler as single treatment
Filler as single treatment at initial treatment
干预措施: Restylane or Emervel filler (Device)
Filler as single treatment
Filler as single treatment at initial treatment
干预措施: Restylane Skinbooster (Device)
结局指标
主要结局
Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance
时间窗: 7 months
Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
次要结局
- Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance(1, 7 and 13 months)
- Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator(1, 7, and 13 months)
- Number of Participants Satisfied With Facial Appearance(7 and 13 months)
- Number of Participants for Which the Investigator is Satisfied With the Outcome(7 and 13 months)
- Percentage of Subjects Improved in Wrinkle Severity Score(7 and 13 months)
- Injected Volume of Study Products at Initial Single Treatment(Baseline)