MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Brimonidine 0.33% gel (Br)
* Other: CD07805/47 (Br) placebo gel
* Drug: Ivermectin 1% cream (IVM)
* Other: CD5024 (IVM) placebo cream


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or female subjects age 18 years or older; Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face; Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]); Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]); 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; Females subjects of non-childbearing potential; Main Exclusion Criteria: Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea; 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 brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream<br>Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks. | Drug: Brimonidine 0.33% gel (Br)<br> <br> Other: CD07805/47 (Br) placebo gel<br> <br> Drug: Ivermectin 1% cream (IVM)<br> <br> |
| Placebo Comparator: CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream<br>Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. | Other: CD07805/47 (Br) placebo gel<br> <br> Other: CD5024 (IVM) placebo cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): | Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1) | week 12/Hour 3 |