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NCT04763265 · ClinicalTrials.gov registry record · Phase 2
Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
A Phase 2 study, sponsored by Croma-Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 208
- Enrollment target
NCT04763265: Completed Phase 2 study, sponsored by Croma-Pharma.
NCT04763265 is a Phase 2 study that has completed, run by Croma-Pharma. The registered enrollment target is 208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04763265, a Phase 2 study, has completed, sponsored by Croma-Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 208 participants
- Enrollment target
Study Summary
The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.
Primary Outcome
The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS score
Interventions
- BIOLOGICAL Botulinum toxin A "BoNT/A-DP"
- BIOLOGICAL Botulinum toxin A "Botox Cosmetics"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2021-02-01 |
| Phase | Phase 2 |
What the finished NCT04763265 record still lists
NCT04763265 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 2 interventions - of which Botulinum toxin A "BoNT/A-DP" is the first listed.
NCT04763265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04763265 about?
NCT04763265 is a clinical study titled "Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines". The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.
What is the current status of trial NCT04763265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2020-06-24. Estimated completion is 2021-02-01.
What interventions are being tested in trial NCT04763265?
The interventions under investigation include: Botulinum toxin A "BoNT/A-DP" (BIOLOGICAL), Botulinum toxin A "Botox Cosmetics" (BIOLOGICAL).
Who is sponsoring clinical trial NCT04763265?
This trial is sponsored by Croma-Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04763265's enrollment target sits among peer trials
208 294th of 2000 higher than 1,704 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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