Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT02718118
Brief Summary:
This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines.
1. To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) at maximum frown line on Day 30.
2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.
3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator).
4. To assess the subject's satisfaction with the treatment.
5. To evaluate investigator satisfaction of treatment outcome.
6. To evaluate subject psychological well-being.
7. To evaluate subject age appraisal.
8. To evaluate all adverse events during the course of the study.
Detailed Description:
Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.
Study:
NCT02718118
Study Brief:
Protocol Section:
NCT02718118