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The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with rosacea-related inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oracea® | Active Comparator | Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules |
|
| placebo | Active Comparator | placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Inflammatory Lesion Counts | Mean change in inflammatory lesion counts from baseline to week 12 | baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12 | Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 [LL-37] peptide. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Therapeutics Clinical Research |
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First subject enrolled 9 May 2011, last subject last visit 2 July 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Oracea® | Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules for 12 weeks |
| FG001 | Placebo Capsules | Placebo capsules for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Other | Placebo, oral, one capsule daily in the morning |
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| baseline to week 12 |
| Investigator's Global Assessment (IGA) Scores at Week 12 | Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst. | Week 12 |
| Change From Baseline in Clinician's Erythema Assessment (CEA) Scores | Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst. | baseline to week 12 |
| San Diego |
| California |
| 92123 |
| United States |
| Hudson Dermatology | Evansville | Indiana | 47714 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Michigan Center for Research Corp | Clinton Township | Michigan | 48038 | United States |
| Skin Search of Rochester, Inc | Rochester | New York | 14623 | United States |
| Oregon Medical Research Center, PC | Portland | Oregon | 97223 | United States |
| Derm Research | Austin | Texas | 78759 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| Suzanne Bruce and Associates, PA | Houston | Texas | 77056 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oracea® | Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules |
| BG001 | Placebo | placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change From Baseline in Inflammatory Lesion Counts | Mean change in inflammatory lesion counts from baseline to week 12 | Posted | Mean | Standard Deviation | inflammatory lesions | baseline to week 12 |
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| Secondary | Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12 | Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 [LL-37] peptide. | Treatment success was defined as all subjects from either treatment group with a score of clear or near clear on the Investigator's Global Assessment (IGA) scale. Treatment failure was defined as all subjects from either treatment group with a score of mild, moderate, or severe on the IGA scale. | Posted | Mean | Standard Deviation | micr grams protein | baseline to week 12 |
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| Secondary | Investigator's Global Assessment (IGA) Scores at Week 12 | Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst. | Posted | Number | participants | Week 12 |
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| Secondary | Change From Baseline in Clinician's Erythema Assessment (CEA) Scores | Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst. | Posted | Mean | Standard Deviation | units on a scale | baseline to week 12 |
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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 | Oracea® | Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules | 2 | 84 | 8 | 84 | ||
| EG001 | Placebo | placebo | 0 | 86 | 6 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | MedDRA | unlikely related to study drug |
| |
| Spontaneous abortion | Pregnancy, puerperium and perinatal conditions | MedDRA | Not related to study drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| upper respiratory infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Warren Winkelman | Galderma Laboratories | 817-961-5494 | warren.winkelman@galderma.com |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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