Oracea Soolantra Association in Participants With Severe Rosacea
NCT ID: NCT03075891
Last Updated: 2021-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
273 participants
INTERVENTIONAL
2017-07-05
2018-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ivermectin 1% cream + Doxycycline 40 mg MR capsules
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
Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules
1 Capsule once-daily for 12 weeks
Ivermectin 1% cream + Oral placebo capsules
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
Oral placebo capsules
1 Capsule once-daily for 12 weeks
Interventions
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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
Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules
1 Capsule once-daily for 12 weeks
Oral placebo capsules
1 Capsule once-daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face at Baseline visit;
* Subject with severe rosacea with papulopustular lesions (according to the Investigator's Global Assessment (IGA) score rated 4);
* Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
* Female subjects of childbearing potential must practice a highly effective method of contraception during the study.
Exclusion Criteria
* Subjects with more than 2 nodules of rosacea on the face;
* Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
* Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients doxycycline and ivermectin.
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Private Practice
Fort Smith, Arkansas, United States
Private practice
Sacramento, California, United States
Private practice
Boca Raton, Florida, United States
Private practice
Louisville, Kentucky, United States
Private practice
Louisville, Kentucky, United States
Private Practice
Metairie, Louisiana, United States
Private practice
Omaha, Nebraska, United States
Private practice
Las Vegas, Nevada, United States
Private practice
Pflugerville, Texas, United States
Private practice
Markham, , Canada
Private practice
Montreal, , Canada
Private practice
Peterborough, , Canada
Private practice
Richmond Hill, , Canada
Private practice
Waterloo, , Canada
Private practice
Budapest, , Hungary
University
Debrecen, , Hungary
Hospital
Miskolc, , Hungary
Private practice
Pécel, , Hungary
University
Pécs, , Hungary
University
Szeged, , Hungary
Private practice
Szolnok, , Hungary
Countries
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Provided Documents
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Document Type: Study Protocol: Version for all countries except Germany
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.03.SPR.113322
Identifier Type: -
Identifier Source: org_study_id
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