Moderate to severe glabellar lines MedDRA version: 13.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Dysport RU
Product Code: Dysport RU
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Other descriptive name: BOT
Sponsors
Ipsen Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Provision of written informed consent prior to any study related procedures. (2) Be female between 30 and 60 years of age, inclusive. (3) Have moderate to severe vertical glabellar lines at maximum frown at Day 1 (baseline, pre-treatment), as assessed by the Investigator’s and subject’s assessment using a validated 4-point Photographic Scale. (4) Be naïve to previous treatment with any serotype of BTX. (5) Have a negative pregnancy test (for females of childbearing potential only). Nonchildbearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation at least three months before entering screening, or hysterectomy. (6) Have both the time and ability to complete the study and comply with study instructions. (7) Have an understanding of the study and the contents of the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: (1) Previous treatment with any serotype of BTX. (2) A history of silicone injections into upper face within the previous 5 years. (3) Any prior treatment with permanent or semi-permanent dermal fillers in the glabellar region within the previous 5 years and/or skin abrasions or photorejuvenation within the previous 12 months. (4) Any planned facial cosmetic surgery during the study period. (5) A history of ablative skin resurfacing of the area to be treated during the study. (6) A history of upper eyelid blepharoplasty or brow lift within the previous 5 years. (7) An inability to substantially reduce glabellar lines by physically spreading them apart. (8) An active infection or other skin problem in the glabellar area (e.g. acute acne lesions or ulcers). (9) Concurrent therapy which, in the Investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study treatment. (10) Pregnant women, nursing mothers, or women who are planning a pregnancy during the study, or think 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) A history of chronic drug or alcohol abuse. (12) Receipt of any 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. (13) Known allergy or hypersensitivity to any serotype of BTX or any component of Dysport RU or Dysport. (14) Clinically diagnosed anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject’s participation in the study. (15) Use of medications that affect neuromuscular transmission, such as curare-like nondepolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics. (16) A history of facial nerve palsy. (17) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin. (18) 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 judgment 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 primary objective is to assess the dose response versus placebo of a single treatment with Dysport RU used for the improvement in the appearance of moderate to severe glabellar lines at maximum frown.;Secondary Objective: The secondary objective is to assess the relative safety and efficacy of Dysport RU compared to Dysport when used for the improvement in appearance of moderate to severe glabellar lines.;Primary end point(s): The co-primary efficacy endpoints for this study will be the proportion of responders at Day 29 in the Investigator’s live assessment of glabellar lines at maximum frown and the subject’s self-assessment of glabellar lines at maximum frown.;Timepoint(s) of evaluation of this end point: D29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects, assessed as responders on Day 29, by both the Investigator’s live assessment and the subject’s self-assessment at maximum frown. • The proportion of responders at maximum frown on Days 8, 15, 57, 85 and 113 as measured by the Investigator’s live assessment. • The proportion of responders at maximum frown on Days 8, 15, 57, 85 and 113 as measured by the subject’s self-assessment. • The proportion of subjects, assessed as responders on Days 8, 15, 57, 85 and 113, by both the Investigator’s live assessment and the subject’s self-assessment at maximum frown. • The proportion of responders at rest on Days 8, 15, 29, 57, 85 and 113 as measured by the Investigator’s live assessment. • The proportion of responders at maximum frown on Day 29 who remain responders on Day 113. • The proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown (e.g. change from baseline severity of glabellar lines from 3 (severe) to 1 (mild) or from baseline severity of 2 (moderate) to 0 (none) after treatment) on Days 8, 15, 29, 57, 85 and 113 as measured by the Investigator’s live assessment. • The proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at rest (e.g. change from baseline severity of glabellar lines from 3 (severe) to 1 (mild) or from baseline severity of 2 (moderate) to 0 (none) after treatment) on Days 8, 15, 29, 57, 85 and 113 as measured by the Investigator’s live assessment. • The proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown (e.g. change from baseline severity of glabellar lines from 3 (severe) to 1 (mild) or from baseline severity of 2 (moderate) to 0 (none) after treatment) on Days 8, 15, 29, 57, 85 and 113 as measured by the subject’s self-assessment.;Timepoint(s) of evaluation of this end point: Days 8, 15, 29, 57, 85 and 11 | — |
Countries
Germany
Outcome results
None listed