EUCTR2014-001860-36-IE进行中（未招募）1 期
Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •male or female, 18 years of age or older
- •horizontal, symmetrical FHL of moderate to severe rating at maximum eyebrow elevation as assessed by both the subject and the investigator using the FWS at day 1 prior to study treatment; investigator and subject baseline FHL ratings at maximum eyebrow elevation must be identical
- •GL of moderate to severe rating at maximum frown as assessed by the investigator using the FWS at day 1 prior to study treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •prior exposure to botulinum toxin of any serotype for any reason
- •any of the following procedures or treatments occurring in the specified period prior to enrollment (day 1)
- •- 3 months: any facial nonablative resurfacing laser or light treatment, microdermabrasion, or superficial peels
- •- 6 months: any facial cosmetic procedure with medium depth or deep depth facial chemical peels (eg, trichloroacetic acid and phenol); periorbital, midfacial, or upper facial skin resurfacing; or permanent make-up in the midfacial (extending from inferior orbital margin to level of the nasal base) or upper facial areas
- •- 12 months: any periorbital, midfacial, or upper facial treatment with nonpermanent soft tissue fillers, or treatment with oral retinoids
- •prior periorbital surgery, facial lift (full-face or mid-face), thread lift, eyebrow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery)
- •prior periorbital, midfacial, or upper facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation
- •marked periocular and eyebrow asymmetry assessed by the investigator at maximum contraction (maximum eyebrow elevation for FHL and maximum frown for GL) or rest
- •marked dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator
- •any eyebrow ptosis or eyelid ptosis at baseline, or excessive forehead and eyebrow skin laxity, as determined by the investigator
- •eyelid folds that reach the pupil or touch the upper lash line
- •use of the frontalis muscle to move the upper eyelid, as assessed by the investigator
- •females who are pregnant, nursing, or planning a pregnancy during the conduct of the study
研究者
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