Papulopustular Rosacea Clinical Trial
Official title:
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Verified date | January 2016 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: - Men and women - 25-70 years - Diagnosis of papulopustular rosacea - Eligible for Oracea treatment Exclusion Criteria: - Allergies to components of investigational product and/or hypersensitivity to tetracyclines - Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit - Used topical rosacea treatment within 30 days prior to baseline visit - Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist - Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics - Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study - Have planned surgical procedures during the course of the study - Have used tetracycline antibiotics within 30 days prior to baseline visit or during study - At risk in terms of precautions, warnings, and contraindications |
Country | Name | City | State |
---|---|---|---|
United States | Stephens & Associates Dallas Research Center | Carrollton | Texas |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
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) | 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 | 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. | Week 2, 6, and 12 |
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