A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

Study Overview
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Brief Summary
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The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.

Detailed Description
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This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02. Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs. Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.

Official Title
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A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Drug: DRM02
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 to 70 years of age. Clinical diagnosis of rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules. Subjects willing to minimize external factors that might trigger rosacea flare-ups. Male or non-pregnant, non-lactating females. Signed informed consent. Exclusion Criteria: Severe self-reported facial sensitivity. Severe sun sensitivity. Ocular-only, phymatous rosacea or steroid rosacea. Use of topical rosacea treatments in the 4 weeks prior to baseline. Use of systemic corticosteroids within the 4 weeks prior to baseline. Use of systemic antibiotics in the 4 weeks prior to baseline. Use of systemic retinoids for in the 6 months prior to baseline. Use of topical retinoids in the 3 months prior to baseline. Use of light- or laser-based rosacea treatments in the past 2 months prior to baseline. Cosmetic procedures within the 2 months prior to baseline. Use of topical anti-aging medications in the 2 weeks prior to baseline. Subjects who have poor skin condition within 5 cm of the treatment area. Subjects who are current drug or alcohol abusers; have a history of immunodeficiency or are a poor medical risk because of other systemic diseases or active uncontrolled infections. Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy. Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days. Subjects who have a clinically significant laboratory value at screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRM02<br>DRM02 Topical Gel, 0.25% | Drug: DRM02<br> <br> |
| Placebo Comparator: Vehicle<br>DRM02 Topical Gel, Vehicle | Other: Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory lesion count |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Evaluation (IGE) |  | From baseline to weeks 0, 1, 2, 3, 4 and 6 | 
| IGE dichotomized into success and failure |  | Week 6 | 
| Percent change in inflammatory lesions |  | Week 6 |