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NCT02840461 · ClinicalTrials.gov registry record · Phase 3
Clinical Endpoint Study of Ivermectin 1% Cream
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 630
- Enrollment target
NCT02840461: Completed Phase 3 study, sponsored by Actavis.
NCT02840461 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 630 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02840461, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 630 participants
- Enrollment target
Study Summary
A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of moderate to severe papulopustular rosacea.
Primary Outcome
Bioequivalence of the test to reference was considered to have been demonstrated if the 90% confidence interval for the test to reference ratio for the percent change from baseline to Week 12 in the number of inflamed lesion counts was within \[80%, 125%\].
Interventions
- DRUG Ivermectin Cream, 1%
- DRUG Placebo/Vehicle cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2016-06 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT02840461 record still lists
NCT02840461 is an interventional study that assigns participants to a tested intervention. The registered 630 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 (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Ivermectin Cream, 1% is the first listed.
NCT02840461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02840461 about?
NCT02840461 is a clinical study titled "Clinical Endpoint Study of Ivermectin 1% Cream". A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of moderate to severe papulopustula...
What is the current status of trial NCT02840461?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 630 participants. The study started on 2016-06. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02840461?
The interventions under investigation include: Ivermectin Cream, 1% (DRUG), Placebo/Vehicle cream (DRUG).
Who is sponsoring clinical trial NCT02840461?
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 NCT02840461's enrollment target sits among peer trials
630 581st of 2000 higher than 1,417 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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