跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT02677298
NCT02677298已完成3 期

Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo, Followed by an Open Label Extension Study

Croma-Pharma GmbH18 个研究点 分布在 3 个国家目标入组 784 人开始时间: 2016年3月2日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
784
试验地点
18
主要终点
Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.

详细描述

This multicenter Phase 3 study is comprised of two parts. The first part of the study is a randomized, double blind, placebo-controlled, phase which aims to demonstrate efficacy and safety of BoNT/A-DP compared with placebo. The second part is an open label extension phase to evaluate efficacy after repeat treatments and long term safety. Subjects can receive a maximum of four treatment cycles over the duration of the study, a single treatment in the first cycle compared with placebo, and up to three subsequent treatments in the open label extension study.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Aged ≥ 18 years or older at the time of screening (upper limit 75 years, inclusive).
  • •Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as determined by in-clinic assessments by both the investigator and the subject (where: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe').
  • •Subject has a stable medical condition with no uncontrolled systemic disease.
  • •Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study. Such methods include for example: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion or vasectomized partner.
  • •Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the FWS), without glasses obstructing the forehead area.
  • •The moderate to severe glabellar lines have an important psychological impact on the subject, as indicated by scores >0 on either the Emotional or Functioning subscales of the modified Skindex-16 (GL-QoL).

排除标准

  • •Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to screening, or any planned treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment).
  • •Known hypersensitivity to the study medication or its excipients.
  • •Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.
  • •Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the 3 months prior to screening or planned during the study.
  • •Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers,) within 12 months prior to screening or planned during the study.
  • •Previous insertion of permanent material in the glabellar area or planned during the study.
  • •Any surgery, or history of surgery, in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these, or scars in the glabellar area, or such surgery planned during the study.
  • •Active skin disease/infection or irritation at the treatment area.
  • •Inability to substantially lessen glabellar frown lines even by physically spreading them apart.
  • •Use of a muscle relaxant within 2 weeks prior to screening or planned during the study.
  • •Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator.
  • •Pregnant, breastfeeding or planning to become pregnant during the trial.
  • •Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to screening or planned during the study.
  • •Planned surgery with general anaesthetic (use of local anaesthetic outside the glabellar area is permitted).
  • •Participation in another clinical study within one month of screening and throughout the trial.
  • •Previous participation in another botulinum toxin aesthetic study which involved the treatment of glabellar lines in combination with canthal lines and/or forehead lines in the previous 18 months.
  • •Chronic drug or alcohol abuse (as per investigator discretion).
  • •Eligibility Criteria for re-treatment: The following criteria MUST be met for re-treatment:
  • •At time of re-treatment subject does not have relevant changes to their health status from enrollment, which would have prevented subject's entry into the study according to the inclusion and exclusion criteria
  • •The subject must have been randomized to receive treatment and must have received at least one treatment (BoNT/A-DP or placebo).
  • •A minimum of 12 weeks must have elapsed since the previous study treatment.
  • •The subject's glabellar lines at maximum frown must have relapsed to a FWS score of 2 or 3 as determined by the investigator and the subject.
  • •No relevant infection or inflammation in the planned injection area.
  • •Negative urine pregnancy test, in women of child-bearing potential.
  • •The subject must have received fewer than four study treatments.
  • •The subject must agree and consent to re-treatment.
  • •Re-treatment will be performed at the latest by week 48.

研究组 & 干预措施

Botulinum toxin A

Experimental

Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.

干预措施: Botulinum Toxin A (Drug)

Placebo

Placebo Comparator

Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area.

干预措施: Placebo (Drug)

Botulinum toxin A Open Label Extension Arm

Experimental

Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles.

20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.

干预措施: Botulinum Toxin A (Drug)

结局指标

主要结局

Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments.

时间窗: Week 4

The primary endpoint is the percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles.

次要结局

  • Change From Baseline of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Erythrocytes(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Erythrocytes MCHC, Hemoglobin(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Erythrocyte MCV(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Systolic and Diastolic Blood Pressure(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Pulse Rate(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Number of Participants With Normal and Abnormal Electrocardiogram(Last visit of Treatment Cycle 1 (End of Cycle procedures) conducted upon confirmation of eligibility for retreatment, which was assessed starting 12 weeks post-treatment with 4-weekly evaluations up to a maximum of 48 weeks post treatment.)
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) Events of Special Interest (AESIs)(Through study completion (60 weeks))
  • Number of Participants With Neutralizing Anti-Drug Antibodies(Through study completion (60 weeks))
  • Change From Baseline of Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Bilirubin and Creatinine(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Blood Urea Nitrogen, Cholesterol, Glucose, Potassium, Sodium(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Change From Baseline of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets(Week 4 after treatment in treatment cycle 1, 2, 3 and 4)
  • Percentage of Responders at Maximum Frown at Week 12(Week 12)
  • Percentage of Responders at Week 16(Week 16)
  • The Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest at Week 4 Based Separately on the Investigators´ and the Subjects´ In-clinic Assessments(Week 4)
  • Percentage of Responders at Week 20 or Later (After the First Treatment).(Week 20, 24, 28, 32 of Treatment Cycle 1)
  • Extent of Change in Psychological Impact(Week 4)
  • Responder Rate at Weeks 1, 2 and 8(Week 1, Week 2, and Week 8)
  • The Percentage of Subjects With ≥ 2-point Reduction in Facial Wrinkle Scale (FWS) Score (at Maximum Frown)(Week 2, 4, 12, 16 and 20)
  • Time to Onset of Effect in the BoNT/A-DP and Placebo Groups in the First Treatment Cycle(From treatment at Day 0 to Week 4 in Treatment Cycle 1)
  • Satisfaction With Treatment, During Each Treatment Cycle, as Assessed by the Validated FACE-Q Satisfaction With Outcome Scale.(Week 4 of Treatment Cycles 1, 2, 3 and 4)
  • The Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest Based on the Independent Rater's Assessment of Photos.(Week 2, 4, 12, 16, 20, 24 and 28 of Treatment Cycle 1)
  • Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at 4 Weeks After Re-treatment Relative to the Rating at the Preceding End-of-Cycle Visit.(Week 4 of Treatment Cycles 2, 3 and 4)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (18)

Loading locations...

相似试验

已完成
3 期
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII)Glabellar Frown Lines
NCT03985982Croma-Pharma GmbH410
已完成
3 期
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study IIGlabellar Frown Lines
NCT02677805Croma-Pharma GmbH251
已完成
3 期
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2PFIC1PFIC2
NCT03566238Albireo62
已完成
3 期
OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)Hereditary Angioedema
NCT05139810Ionis Pharmaceuticals, Inc.91
已完成
3 期
Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 StudyMigraine
NCT02614196Eli Lilly and Company986