The purpose of this clinical study is to assess safety and efficacy of different doses of Dysport® RU (RU= Ready to Use), a new formulation of a drug called Dysport®, which is used for the improvement in the appearance of glabellar lines (lines that appear on the forehead between the eyebrows).Additionally, the study will aim to establish the dose of Dysport® RU, which is equivalent in terms of safety and efficacy to the optimal dose of 50 U of Dysport®.
- Conditions
- Moderate to severe glabellar linesMedDRA version: 13.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Body processes [G] - Physical Phenomena [G01]
- Registration Number
- EUCTR2010-019085-82-DE
- Lead Sponsor
- Ipsen Innovation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 160
(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
(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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method