Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Detailed Description
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Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Official Title
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A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea

Conditions
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Erythema, Rosacea

Intervention / Treatment
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* Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle
* Drug: azelaic acid gel 15%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female aged 18 years or older. Subject has a clinical diagnosis of facial rosacea. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment. Subject has a self assessment score of moderate to severe redness prior to enrollment. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment. Exclusion Criteria: Female subjects who are pregnant, nursing or planning a pregnancy during the study. Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study. Subjects with conditions causing facial erythema which would confound the assessment of treatment. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists. Subjects with known allergies or sensitivities to one of the components of the investigational products.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overall Study<br>In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence. During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days). | Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle<br>* To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily<br>* Other names: brimonidine tartrate gel vehicle;Drug: azelaic acid gel 15%<br>* During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily<br>* Other names: Finacea® gel 15%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Success | Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period | Hour 6 on Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Action | Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application | 30 minutes after baseline treatment application on Day 15 |