Proof-of-concept study: Testing the efficacy and tolerability of botulinum toxin (Xeomin®) in the treatment of crow's feet compared to Vistabel® in an intra-individual comparison

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Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: Xeomin Pharmaceutical Form: Powder for injection* Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 100‐ Trade Name: Vistabel Pharmaceutical Form: Powder for injection* CAS Number: 8000049323 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 50‐ CONDITION: Moderate to severe crow`s feet ; MedDRA version: 9.1 Level: LLT Classification code 10052611 Term: Crow's feet PRIMARY OUTCOME: Main Objective: Evaluate group differences in the treatment of crows feet with assessed. 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 between 18 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.
Epistemonikos ID: d3d12fb80d89bd9886e894c7b7b63027589e7f3c
First added on: Aug 21, 2024
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