EUCTR2014-005301-21-DE进行中（未招募）1 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines - MT10109L in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal
Allergan Ltd.0 个研究点目标入组 375 人开始时间: 2018年12月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 375
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
- •- Participant must be = 18 years of age and considered to be an adult in her/his local jurisdiction at the time of signing the informed consent.
- •- Moderate to severe glabellar lines (GL) at maximum frown (assessed by both the investigator and participant; investigator and participant ratings must be the same for GL) and bilaterally symmetrical moderate to severe LCL at maximum smile (same grade on both sides of the face as assessed by the investigator only), using the Facial Wrinkle Scale with Photonumeric Guide (FWS)
- •- Participants must have sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial lines, in the opinion of the investigator.
- •- Male and female
- •- Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
- •- Female participants of childbearing potential must have a negative urine pregnancy test before study intervention. A female is considered NOT to be of childbearing potential if she is premenarchal, postmenopausal (at least 12 consecutive months without menstruation), or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral ophorectomy).
- •- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •- Written informed consent from the participant has been obtained prior to any study related procedures.
- •- Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
- •- Ability to follow study instructions, including completing study assessment tools without any assistance or alteration to the assessment tools and likely to complete all required visits
- •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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Any condition which precludes a participant’s ability to comply with study requirements, including completion of the study visits or inability to read, understand, and/or self-assess glabellar lines (GL) severity using the Facial Wrinkle Scale with Photonumeric Guide (FWS)
- •- Known immunization or hypersensitivity to any botulinum toxin serotype
- •- Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- •- Any history of significant cardiovascular disease, family history of long QT syndrome, or a clinically significant electrocardiogram (ECG) abnormality at the Screening Visit
- •- Marked facial asymmetry, 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 brow or eyelid ptosis, as determined by the investigator
- •- Infection or skin disorder at the injection sites
- •- History of facial nerve palsy
- •- Any uncontrolled systemic disease
- •- Recent history of alcohol or drug abuse based on the investigator’s judgment
- •- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention)
- •- Anticipated need for surgery or overnight hospitalization during the study
- •- Prior exposure to botulinum toxin of any serotype for any reason
- •- Any of the following procedures or treatments occurring in the specified period before enrollment (Day 1):
- •3 months: any facial nonablative resurfacing laser, light or ultrasound treatment, microdermabrasion, or superficial peels
- •6 months: any facial cosmetic procedure with medium depth or deep depth chemical peels (eg, trichloroacetic acid [TCA] and phenol); periorbital, mid-facial, or upper-facial skin resurfacing; or permanent make-up in the mid-facial (extending from inferior orbital margin to level of the nasal base) or upper facial areas
- •12 months: any periorbital, mid-facial, or upper-facial treatment with nonpermanent soft tissue fillers
- •- Participants on topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 6 months before enrollment and who are unable to maintain the same regimen for the study
- •- Participants on oral retinoid therapy within 1 year before study enrollment
- •- Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery)
- •- Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation
- •- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- •- Females who are pregnant, nursing, or planning a pregnancy during the study
- •- Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits
- •- Participants who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period
- •- The participant has a condition or is
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