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This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD07805/47 0.5% Topical Gel | Experimental | 0.5% Topical Gel |
|
| CD07805/47 0.18% Topical Gel | Experimental | 0.18% Topical Gel |
|
| CD07805/47 0.07% Topical Gel | Experimental | 0.07% Topical Gel |
|
| CD07805/47 Vehicle Topical Gel | Placebo Comparator | Vehicle Topical Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD07805/47 | Drug | 0.5% Topical Gel |
| |
| CD07805/47 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. | Baseline and every hour for 12 hours following application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Philadephia Institute of Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD07805/47 0.5% Topical Gel | 0.5% Topical Gel |
| FG001 | CD07805/47 0.18% Topical Gel | 0.18% Topical Gel |
| FG002 | CD07805/47 0.07% Topical Gel | 0.07% Topical Gel |
| FG003 | CD07805/47 Vehicle Topical Gel | Vehicle Topical Gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD07805/47 0.5% Topical Gel | 0.5% Topical Gel |
| BG001 | CD07805/47 0.18% Topical Gel | 0.18% Topical Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. | Posted | Number | participants | Baseline and every hour for 12 hours following application |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD07805/47 0.5% Topical Gel | 0.5% Topical Gel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Graeber, MD | Galderma | 609-860-8201 | michael.graeber@galderma.com |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
0.18% Topical Gel |
|
| CD07805/47 | Drug | 0.07% Topical Gel |
|
| CD07805/47 placebo | Drug | Vehicle Topical Gel |
|
| Fort Washington |
| Pennsylvania |
| 19034 |
| United States |
| Derm Research, Inc | Austin | Texas | 78759 | United States |
| J&S Studies | College Station | Texas | 77845 | United States |
| The Education & Research Foundation | Lynchburg | Virginia | 24501 | United States |
| BG002 |
| CD07805/47 0.07% Topical Gel |
0.07% Topical Gel |
| BG003 | CD07805/47 Vehicle Topical Gel | Vehicle Topical Gel |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 |
| CD07805/47 Vehicle Topical Gel |
Vehicle Topical Gel |
|
|
| 0 |
| 31 |
| 4 |
| 31 |
| EG001 | CD07805/47 0.18% Topical Gel | 0.18% Topical Gel | 0 | 31 | 1 | 31 |
| EG002 | CD07805/47 0.07% Topical Gel | 0.07% Topical Gel | 0 | 28 | 3 | 28 |
| EG003 | CD07805/47 Vehicle Topical Gel | Vehicle Topical Gel | 0 | 32 | 5 | 32 |
| Skin Irritation | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
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