Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oracea | Experimental | Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oracea | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rosacea Score on the Visual Analog Scale | VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable | Baseline, Weeks 2, 6, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Rosacea-Specific Quality of Life Index | ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time) | Baseline, Weeks 2, 6, and 12 |
| Patient Global Assessment (PGA) of Rosacea Scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephens & Associates Dallas Research Center | Carrollton | Texas | 75006 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oracea | Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oracea | Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rosacea Score on the Visual Analog Scale | VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable | Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 6, and 12 |
|
|
12 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oracea | Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M Nieman | Galderma Laboratories, L.P. | 817-961-5000 | elizabeth.nieman@galderma.com |
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules
| Baseline, Weeks 2, 6, and 12 |
| Patient Satisfaction Question | The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea. | Week 2, 6, and 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Years since the first rosacea diagnosis | Mean | Standard Deviation | years |
|
| Skin type | Number | participants |
|
| Fistzpatrick Skin Type | Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Rosacea-Specific Quality of Life Index | ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time) | Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 6, and 12 |
|
|
|
| Secondary | Patient Global Assessment (PGA) of Rosacea Scores | Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules | Posted | Number | participants | Baseline, Weeks 2, 6, and 12 |
|
|
|
| Secondary | Patient Satisfaction Question | The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea. | Posted | Number | participants | Week 2, 6, and 12 |
|
|
|
| 0 |
| 24 |
| 7 |
| 24 |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Week 12 |
|
| Week 2 |
|
| Week 6 |
|
| Week 12 |
|
| Week 6 |
|
| Week 12 |
|