A prospective, multicenter, randomized, rater- and subject-blind, parallel group trial to investigate the non-inferiority of NT 201, free of complexing proteins, in comparison with Clostridium botulinum toxin type A in the treatment of glabellar frown line - NT-H2H

• Conditions: Treatment of glabellar frown lines; MedDRA version: 10.1Level: LLTClassification code 10052609Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-002713-40-GB
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-07
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 384

Inclusion Criteria

- Female with moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as assessed by the investigator’s rating
- Age between 18 and 50 (inclusively)
- Willing and able to complete the entire course of the trial and to comply with trial instructions
- Written informed consent
- For females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at screening and at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the entire duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner (def. see protocol)
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

Exclusion Criteria

- Severe glabellar frown lines at rest, according to investigator’s rating on FWS
- Previous treatment with Botulinum neurotoxin of any serotype in the upper third part of the face within the last 6 months, e.g., treatment of glabellar area, forehead lines, crow’s feet, bunny lines, eyebrow lifting
- Previous treatment with biodegradable fillers in the glabellar area within the last 12 months
- Previous insertion of permanent material in the glabellar area, including fat graft
- Previous treatment with any facial cosmetic procedure photo in the glabellar area within the last 6 months
- Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these
- Any scars in the glabellar are
- Any other planned cosmetic procedure in the upper third part of the face during the trial period
- Marked facial asymmetry
- Ptosis of eyelid and/or eyebrow
- Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face
- History of facial nerve palsy
- Any infection in the area of injection sites
- Any medical condition that may put the subject at increased risk with exposure to NT 201, including myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function
- Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumour, or medical history of HIV infection or any findings from laboratory or physical examination performed at screening
-Bleeding disorders or intake of drugs in doses that will lead to an anticoagulative effect (e.g. heparin, cumarines, clopidogrel, non-steroidal anti-inflammatory drugs, acetylsalicylic acid) 10 days before injection
-Intake of any of the forbidden concomitant medication, e.g. amino glycoside antibiotics, or other agents that might interfere with neuromuscular function (e.g. D-penicillin amine, curarine-type muscle relaxants, succinylcholine) or might interfere with the action of Botulinum neurotoxin (e.g. chloroquine)
- Known allergy or sensitivity to the trial medication or its components
- Evidence or suspicion that the subject might not comply with the study directives and/or that he/she is not reliable or trustworthy
- Evidence or suspicion that the subject is not willing or unable to understand the information that is given to him/her as part of the informed consent, in particular regarding the risks and discomfort to which he/she would agree to be exposed
- Evidence of recent alcohol or drug abuse
- Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with trial results
- Participation in another clinical trial within 30 days prior to screening
- Subjects that are imprisoned or are lawfully kept in an institution
- Employees or direct relatives of an employee of the CRO, the Study Centre or Merz Pharmaceutical

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the non-inferiority of NT 201, free of complexing proteins, to Clostridium botulinum toxin type A in the treatment of glabellar frown lines;Secondary Objective: Further evaluation of the treatment effect of NT 201 and its reference on the glabellar frown lines at maximum frown or at rest by the independent raters, investigators at the sites or subjects .;Primary end point(s): The primary efficacy endpoint is defined as the response to the treatment with respect to the FWS at maximum frown as assessed by the independent raters at Visit 3 (Day 28) from photographs. The response is defined as an improvement on the FWS of at least one point from Visit 2 (Baseline Visit) to Visit 3.