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NCT03075891 · ClinicalTrials.gov registry record · Phase 4
Oracea Soolantra Association in Participants With Severe Rosacea
A Phase 4 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 273
- Enrollment target
NCT03075891: Completed Phase 4 study, sponsored by Galderma R&D.
NCT03075891 is a Phase 4 study that has completed, run by Galderma R&D. The registered enrollment target is 273 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03075891, a Phase 4 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 273 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.
Primary Outcome
Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is \[i.e.\] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, ri
Interventions
- DRUG Ivermectin 1% cream
- DRUG Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules
- OTHER Oral placebo capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2018-02-08 |
| Phase | Phase 4 |
What the finished NCT03075891 record still lists
NCT03075891 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Ivermectin 1% cream is the first listed.
NCT03075891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03075891 about?
NCT03075891 is a clinical study titled "Oracea Soolantra Association in Participants With Severe Rosacea". The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.
What is the current status of trial NCT03075891?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 273 participants. The study started on 2017-07-05. Estimated completion is 2018-02-08.
What interventions are being tested in trial NCT03075891?
The interventions under investigation include: Ivermectin 1% cream (DRUG), Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules (DRUG), Oral placebo capsules (OTHER).
Who is sponsoring clinical trial NCT03075891?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03075891's enrollment target sits among peer trials
273 315th of 2000 higher than 1,685 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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