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NCT03168321 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 813
- Enrollment target
NCT03168321: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT03168321 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 813 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03168321, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 813 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.
Primary Outcome
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Interventions
- DRUG IDP-123 Lotion
- DRUG IDP-123 Vehicle Lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2018-06-07 |
| Phase | Phase 3 |
What the finished NCT03168321 record still lists
NCT03168321 is an interventional study that assigns participants to a tested intervention. The registered 813 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which IDP-123 Lotion is the first listed.
NCT03168321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03168321 about?
NCT03168321 is a clinical study titled "A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)". This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.
What is the current status of trial NCT03168321?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 813 participants. The study started on 2017-06-29. Estimated completion is 2018-06-07.
What interventions are being tested in trial NCT03168321?
The interventions under investigation include: IDP-123 Lotion (DRUG), IDP-123 Vehicle Lotion (DRUG).
Who is sponsoring clinical trial NCT03168321?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03168321's enrollment target sits among peer trials
813 407th of 2000 higher than 1,593 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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