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NCT03954444 · ClinicalTrials.gov registry record · Phase 3
A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,105
- Enrollment target
NCT03954444: Completed Phase 3 study, sponsored by Actavis.
NCT03954444 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 1,105 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03954444, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,105 participants
- Enrollment target
Study Summary
A Randomized, Double-blind, Parallel-group, Three-arm, Placebo-controlled, Multi-Site Therapeutic Equivalence Study with Clinical End-points Comparing Test Product "Oxymetazoline hydrochloride Cream, 1%" to Reference Product "RHOFADE™ Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea
Primary Outcome
The primary efficacy endpoint was the proportion of subjects with treatment success at all time points 3, 6, 9, and 12 hours post-application on Day 29. Treatment success was defined as having CEA score at least 2 grades lower than the baseline (Day 1 pre-dose) value. Clinician Erythema Assessment was measured as (0-clear, 1-almost clear, 2-mild, 3-moderate, 4- severe).
Interventions
- DRUG Placebo
- DRUG Oxymetazoline Hydrochloride
- DRUG Rhofade Cream, 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,105 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2020-02-27 |
| Phase | Phase 3 |
What the finished NCT03954444 record still lists
NCT03954444 is an interventional study that assigns participants to a tested intervention. Its 1,105 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03954444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03954444 about?
NCT03954444 is a clinical study titled "A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"". A Randomized, Double-blind, Parallel-group, Three-arm, Placebo-controlled, Multi-Site Therapeutic Equivalence Study with Clinical End-points Comparing Test Product "Oxymetazoline hydrochloride Cream, 1%" to Reference Product "RHOFADE™ Cream, 1%" in the Treatment of Moderate to Severe Persistent Faci...
What is the current status of trial NCT03954444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,105 participants. The study started on 2019-04-15. Estimated completion is 2020-02-27.
What interventions are being tested in trial NCT03954444?
The interventions under investigation include: Placebo (DRUG), Oxymetazoline Hydrochloride (DRUG), Rhofade Cream, 1% (DRUG).
Who is sponsoring clinical trial NCT03954444?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03954444's enrollment target sits among peer trials
1,105 251st of 2000 higher than 1,749 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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