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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 is a Phase 4 study that has completed, run by Galderma R&D. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02718118
The ClinicalTrials.gov registry entry for NCT02718118 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 158 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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