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| Name | Class |
|---|---|
| Accenture | INDUSTRY |
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The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.
Patients must have moderate to severe erythematous (facial redness) rosacea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-101 Cream 0.01% Concentration | Experimental | Low dose |
|
| V-101 Cream 0.06% Concentration | Experimental | Mid-dose |
|
| V-101 Cream 0.1% Concentration | Experimental | Mid-dose |
|
| V-101 Cream 0.15% Concentration | Experimental | High dose |
|
| Vehicle | Placebo Comparator | Cream without an active ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-101 | Drug | Cream QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician's Erythema Assessment | Physician visual evaluation | Day 28 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Self Assessment | Patient assesses their condition | 28 Day Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacy R Smith, MD | Therapeutics Clinical Research | Principal Investigator |
| Michael T Jarratt, MD | Derm Research, PLLC | Principal Investigator |
| Leslie S Baumann, MD | Baumann Cosmetic & Research Institute | Principal Investigator |
| Joseph F Fowler, MD | Dermatology Specialists Research | Principal Investigator |
| Robert T Matheson, MD | Oregon Medical Research Center, PC | Principal Investigator |
| Daniel M Stewart, DO | DBA Michigan Center for Skin Care Research | Principal Investigator |
| Eduardo Tschen, MD | Academic Dermatology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States | ||
| Baumann Cosmetic & Research Institute |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| vehicle | Other | Cream QD |
|
| Miami Beach |
| Florida |
| 33140 |
| United States |
| Dermatology Specialists Research | Louisville | Kentucky | 40202 | United States |
| DBA Michigan Center for Skin Care Research | Clinton Twp | Michigan | 48038 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Oregon Medical Research Center, PC | Portland | Oregon | 97223 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| D013568 | Pathological Conditions, Signs and Symptoms |