Moderate to severe Glabellar lines MedDRA version: 19.0 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 100000004858
Conditions
Interventions
Product Name: BTX-A-HAC NG (Dysport NG)
Product Code: BTX-A-HAC NG (Dysport NG)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
CAS Number: 93384-43
Sponsors
Ipsen Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must fulfil all of following criteria to be included in the study: (1) Provision of written informed consent prior to any study related procedures. (2) Male or female subjects between 18 and 65 years of age. (3) Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at Baseline (Day 1), as assessed by the ILA using a validated 4-point photographic scale. (4) Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at Baseline (Day 1), as assessed by the SSA using a validated 4-point categorical scale. (5) Are dissatisfied or very dissatisfied (Grade 2 or 3) with their glabellar lines at Baseline (Day 1), as assessed by the subject’s level of satisfaction. (6) Have a negative pregnancy test (for females of childbearing potential only). No childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy. (7) Have both the time and the ability to complete the study and comply with study instructions. 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 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if the subject: (1) Previous treatment with any serotype of BTX. (2) Any prior treatment with permanent fillers in the upper face including the glabellar lines area. (3) Any prior treatment with any dermal fillers in the upper face including the glabellar lines area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the past 12 months. (4) Any planned facial cosmetic surgery during the study. (5) A history of eyelid blepharoplasty or brow lifts within the past 5 years. (6) An inability to substantially reduce glabellar lines by physically spreading them apart or lack of capacity to frown. (7) An active infection or other skin problems in the upper face including the glabellar lines area (e.g. acute acne lesions or ulcers). (8) Use of concomitant therapy, which in the investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the IMP, including medications affecting bleeding disorders (antiplatelet agents and/or anticoagulants given for treatment or prevention of cardio/cerebro vascular diseases). (9) Pregnant women, nursing mothers, or women who are planning a pregnancy during the study, or believe they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use a reliable form of contraception (e.g. oral contraceptives for more than 12 consecutive weeks, or spermicide and condoms). (11) Treatment with an experimental drug or use of any experimental device within 30 days prior to the start of the study and during the conduct of the study. (12) Known allergy or hypersensitivity to any component of BTX-A-HAC NG. (13) Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject’s participation in the study. (14) Use of medications that affect neuromuscular transmission, such as curarelike non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days. (15) A history of facial nerve palsy. (16) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin. (17) The presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgement of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to assess short-term efficacy and safety of a single treatment of BTX-A-HAC NG over placebo for the improvement in the appearance of glabellar lines and to assess the long term safety and efficacy of BTX-A-HAC NG after repeated injections. The primary objective will be met by demonstrating the superiority of BTX-A-HAC NG over placebo as measured by the ILA of the appearance of the subject’s glabellar lines at maximum frown on Day 29 of the DB period.;Secondary Objective: • To compare the efficacy of a single treatment of BTX-A-HAC NG to placebo on Day 29 of the DB period as measured by the SSA • To compare the efficacy of a single treatment of BTX-A-HAC NG to placebo at all timepoints of the DB period and to assess repeat-treatments in the OL period as measured by the ILA • To compare the efficacy of a single treatment of BTX-A-HAC NG to placebo at all timepoints of the DB period (except on Day 29) and to assess repeat-treatments in the OL period as measured by the SSA • To compare the efficacy of a single treatment of BTX-A-HAC NG to placebo at all timepoints of the DB period and to assess repeat-treatments in the OL period as measured by the ILA . • To assess the short and long term safety of BTX-A-HAC NG treatment for the improvement in appearance of moderate to severe glabellar lines. • To assess the presence of putative antibodies against BTX-A following single injection with BTX-A-HAC NG or placebo and after repeat-treatments with BTX-A-HAC NG.;Primary end point(s): The primary efficacy endpoint is the proportion of responders at Day 29 DB Cycle 1 as measured by the ILA of glabellar lines at maximum frown.;Timepoint(s) of evaluation of this end point: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints of DB/OL periods include: • The proportion of responders at each post-treatment visit to the study centre as measured by the ILA at maximum frown and at rest • The proportion of responders at each post-treatment visit to the study centre as measured by the SSA at maximum frown • The proportion of responders at each post-treatment visit to the study centre as measured by subject’s level of satisfaction with the appearance of their glabellar lines • The time to onset of treatment response based on the subject’s diary card (DB Cycle 1 only) • Time to retreatment • Mean change from Baseline to all post-treatment visits (except Day 57 OL Cycles 2 to 5) in the Face-Q satisfaction with facial appearance scale, the Face-Q psychological well-being scale and the FACE-Q aging appearance appraisal score VAS. ;Timepoint(s) of evaluation of this end point: 1. each post-treatment visit to the study centre 2. each re-treatment visit | — |
Countries
France, Germany, United Kingdom
Contacts
Public ContactGlobal Drug Development
Ipsen Innovation
Outcome results
None listed