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NCT02718118 · ClinicalTrials.gov registry record · Phase 4
Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
A Phase 4 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT02718118: Completed Phase 4 study, sponsored by Galderma R&D.
NCT02718118 is a Phase 4 study that has completed, run by Galderma R&D. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02718118, a Phase 4 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30.
Interventions
- DEVICE Dysport reconstituted at 1.5 mL (0.05 mL/injection)
- DEVICE Dysport reconstituted at 2.5 mL (0.08 mL/injection)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-04 |
| Est. Completion | 2016-10 |
| Phase | Phase 4 |
What the finished NCT02718118 record still lists
NCT02718118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Dysport reconstituted at 1.5 mL (0.05 mL/injection) is the first listed.
NCT02718118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02718118 about?
NCT02718118 is a clinical study titled "Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines". 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...
What is the current status of trial NCT02718118?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2016-04. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02718118?
The interventions under investigation include: Dysport reconstituted at 1.5 mL (0.05 mL/injection) (DEVICE), Dysport reconstituted at 2.5 mL (0.08 mL/injection) (DEVICE).
Who is sponsoring clinical trial NCT02718118?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02718118's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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