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NCT03985982 · ClinicalTrials.gov registry record · Phase 3
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII)
A Phase 3 study, sponsored by Croma-Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
NCT03985982: Completed Phase 3 study, sponsored by Croma-Pharma.
NCT03985982 is a Phase 3 study that has completed, run by Croma-Pharma. The registered enrollment target is 410 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03985982, a Phase 3 study, has completed, sponsored by Croma-Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
Study Summary
The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.
Primary Outcome
The primary endpoint is the percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 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 scores are a
Interventions
- DRUG Placebo
- DRUG Botulinum Toxin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2020-12-22 |
| Phase | Phase 3 |
What the finished NCT03985982 record still lists
NCT03985982 is an interventional study that assigns participants to a tested intervention. The registered 410 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03985982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03985982 about?
NCT03985982 is a clinical study titled "Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII)". The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.
What is the current status of trial NCT03985982?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2019-04-29. Estimated completion is 2020-12-22.
What interventions are being tested in trial NCT03985982?
The interventions under investigation include: Placebo (DRUG), Botulinum Toxin A (DRUG).
Who is sponsoring clinical trial NCT03985982?
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 NCT03985982's enrollment target sits among peer trials
410 909th of 2000 higher than 1,090 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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