A Phase II, Randomised, Double-Blind Study to Compare the Safety and Efficacy of One Treatment Cycle of Clostridium Botulinum Type A Toxin (50 Units) When Reconstituted from Either a 125 Unit or a 500 Unit Presentation for the Treatment of Glabellar Lines
- Conditions
- Moderate to severe vertical glabellar lines.MedDRA version: 9.1Level: LLTClassification code 10052609Term: Glabellar frown lines
- Registration Number
- EUCTR2007-005958-23-DE
- Lead Sponsor
- Ipsen Group, SCRAS Institut Henri Beaufour
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female subjects between 18 and 65 years of age;
2. Moderate to severe vertical glabellar lines at maximum frown (score of 2 or 3 by the subject's static self-assessment and confirmed by the Investigator’s live assessment, using a 4-point categorical scale (no wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles [3]);
3. Negative pregnancy test result for females of childbearing potential;
4. Time and ability to complete the study and comply with instructions;
5. Understanding of the study and the contents of the informed consent documents. All subjects must provide written informed consent before enrolling into the study.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
(1) Previous treatment with Dysport or any other botulinum toxin or toxin treatment to any areas of the body at any time prior to the study or planned during the study;
(2) Inability to substantially lessen glabellar lines by physically spreading them apart;
(3) Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication;
(4) Active infection in the glabellar area (e.g., acute acne lesions);
(5) Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or who think that they might be pregnant at the start of the study.
(6) Current history of chronic drug or alcohol abuse;
(7) Enrolment in any active study involving the use of investigational devices or drugs within 90 days of the screening visit;
(8) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin;
(9) Neuromuscular junctional disorders (e.g., myasthenia gravis);
(10) Known allergy or hypersensitivity to any botulinum toxin or any component of Reloxin or Dysport;
(11) Concurrent use of medications that affect neuromuscular transmission, such as lincosamides, polymyxins, and aminoglycoside antibiotics affecting the striated muscle;
(12) Presence of any other condition (e.g., neuromuscular disorder or other disorder that could interfere with neuromuscular function) 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;
(13) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
(14) Subjects must not be confined in an institution due to court or administrative order.
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