Prüfung der Wirksamkeit und der Verträglichkeit von Botulinum-Toxin (Xeomin®) in verschiedenen VerdünnungenEvaluation of the Efficacy and Safety of Botulinumtoxin (Xeomin®) in different dilutions

• Conditions: Moderate to severe glabellar frown lines; MedDRA version: 8.1Level: LLTClassification code 10052609Term: Glabellar frown lines

• Registration Number: EUCTR2006-005568-24-DE
• Lead Sponsor: Dermatologikum Hamburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female subjects between 18 and 75 years of age with moderate to severe glabellar frown lines (severity score = 2 as assessed by the investigator according to Facial Wrinkle Scale)
2. Stable medical condition
3. Subject willing and able to realize the entire course of trial and to comply with trial instructions
5. Written informed consent
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous treatment with Botulinum toxin in the glabellar area within the last 6 months prior to study start
2. Any previous insertion of permanent filler material in the glabellar area
3. Previous treatments with facial cosmetic procedures (e.g. dermal filling, chemical peeling, photo rejuvenation) in the glabellar area within the last 9 months prior to study start
4. Planned treatment with Botulinum toxin in any additional body region during the study period
5. Planned additional treatment with any facial cosmetic procedure (e.g. dermal filling, chemical peeling, photo rejuvenation) in the glabellar area during the study participation
6. Any surgical pretreatment or scars in the glabellar area
7. Any infection in the area of the injection sites
8. Known allergy or sensitivity to the trial medication or its components, or any medical condition that may expose the subject to an increased risk by exposure to Xeomin including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function
9. History of facial nerve palsy
10. Bleeding disorders or regular intake of drugs with anticoagulative effect within the last 10 days prior to study start
11. Concurrent use of aminoglycosides (antibiotics) or other agents that might interfere with neuromuscular function or action of Botulinum toxin

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate group differences in the treatment with two different Xeomin dilutions with regard to photo documentation ;Secondary Objective: Efficacy and safety of the two different Xeomin dilutions;Primary end point(s): Global assessment of the glabella frown lines by FWS based on photo documentation