MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
This trial has been completed.
|Treatments||brimonidine 0.33% gel (br), cd07805/47 (br) placebo gel, ivermectin 1% cream (ivm), cd5024 (ivm) placebo cream|
|Start date||December 2015|
|End date||September 2016|
|Trial size||188 participants|
|Trial identifier||NCT02616250, RD.03.SPR.105069|
The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Fort Smith, AR||not available||completed|
|Rogers, AR||not available||completed|
|Sacramento, CA||not available||completed|
|Orlando, FL||not available||completed|
|Omaha, NE||not available||completed|
|New York, NY||not available||completed|
|Pflugerville, TX||not available||completed|
|Surrey, Canada||not available||completed|
|Markham, Canada||not available||completed|
|Peterborough, Canada||not available||completed|
|Richmond Hill, Canada||not available||completed|
|Waterloo, Canada||not available||completed|
|Windsor, Canada||not available||completed|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Efficacy variable: Percentage of patients across the 5 scores of the global rosacea severity grading scale called Investigator's Global Assessment (IGA).
time frame: week 12
All participants at least 18 years old.
Main Inclusion Criteria: 1. Male or female subjects age 18 years or older; 2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face; 3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]); 4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]); 5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT); 6. Female subjects of childbearing potential must practice a highly effective method of contraception during the study; 7. Females subjects of non-childbearing potential; Main Exclusion Criteria: 1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea; 2. Subjects with more than 2 nodules of rosacea on the face; 3. 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; 4. Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
|Official title||Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea|
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