Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-06 @ 12:07 PM
Study NCT ID:
NCT02718118
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2016-03-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multi-Center, Subject- and Evaluator-Blinded, Parallel Comparison of Dysport®, When Reconstituted at 1.5 mL and 2.5 mL, for the Treatment of Moderate to Severe Glabellar Lines.
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: