Trials / Completed
CompletedNCT03075891
Oracea Soolantra Association in Participants With Severe Rosacea
Efficacy Comparison 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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 273 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ivermectin 1% cream | Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks |
| DRUG | Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules | 1 Capsule once-daily for 12 weeks |
| OTHER | Oral placebo capsules | 1 Capsule once-daily for 12 weeks |
Timeline
- Start date
- 2017-07-05
- Primary completion
- 2018-02-08
- Completion
- 2018-02-08
- First posted
- 2017-03-09
- Last updated
- 2021-03-16
- Results posted
- 2019-11-29
Locations
21 sites across 3 countries: United States, Canada, Hungary
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03075891. Inclusion in this directory is not an endorsement.