Proof-of-concept study: Prüfung der Wirksamkeit und der Verträglichkeit von Botulinum-Toxin (Xeomin®) bei der Behandlung von Krähenfüßen im Vergleich zu Dysport® im intraindividuellen Vergleich

• Conditions: Moderate to severe crow`s feet; MedDRA version: 9.1Level: LLTClassification code 10052611Term: Crow's feet

• Registration Number: EUCTR2008-001157-18-DE
• Lead Sponsor: Dermatologikum Hamburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

•Female and male subjects with moderate to severe crow`s feet (severity score of 2 and 3 as assessed by the investigator according to Facial Wrinkle Scale) aged between18 and 65 years
•Stable medical condition
•Able to comply with the requirements of this study protocol
•Written informed consent and data protection statement

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

•Treatment of the upper face with botulinum toxin within 6 month prior to study entry
•Pretreatment with any permanent filler material in the area to be treated
•Any cosmetic pretreatment in the area to be treated (e.g. facial injections of dermal fillers, chemical peeling or photo rejuvenation) within 9 month prior to study entry
•Any additional intended treatment with botulinum toxin in a further localization during the study
•Any additional intended cosmetic treatment in the area to be treated (e.g. facial injections of dermal fillers, chemical peeling or photo rejuvenation) during the study
•Any prior surgery or scars in the area to be treated
•Infections of the injection areas
•Known adverse reactions of any severity or hypersensitivity to any ingredient of Xeomin® or any medical condition with increased risk by exposure to Xeomin, including Myasthenia gravis, Lambert-Eaton Syndrome, Amyotrophic lateral sclerosis or any other interferences with impairment of neuromuscular functions
•Known adverse reactions of any severity or hypersensitivity to any ingredient of Dysport® respectively or any medical condition with increased risk by exposure to botulinum toxin A, including Myasthenia gravis, Lambert-Eaton Syndrome, Amyotrophic lateral sclerosis or any other interferences with impairment of neuromuscular functions
•Palsy of facial nerves
•Coagulation disorders or regular administration of drugs with anticoagulative effect within 10 days prior to study
•Administration of aminoglycosides (antibiotics) or other drugs that may interfere with neuromuscular functions or the efficacy of botulinum toxin
•Alcohol and drug abuse
•Pregnant or breastfeeding women and women who are planning to become pregnant or women of childbearing potential that do not use adequate birth control measures during the trial
•Participation in any other clinical trial within 30 days prior or during this trial

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 of crows feet with Xeomin and Dysport with regard to photo documentation;Secondary Objective: The efficacy and safety of the two different treatments (Xeomin vs. Dysport) will be assessed.;Primary end point(s): Global assessment of the crow`s feet by FWS based on photo documentation (laughing condition)