Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea

Phase 4

Completed

Brief Summary: The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Oracea	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

Primary Outcome Measures

Name	Time	Method
Rosacea Score on the Visual Analog Scale	Baseline, Weeks 2, 6, and 12	VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable

Secondary Outcome Measures

Name	Time	Method
Rosacea-Specific Quality of Life Index	Baseline, Weeks 2, 6, and 12	ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)
Patient Global Assessment (PGA) of Rosacea Scores	Baseline, Weeks 2, 6, and 12	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
Patient Satisfaction Question	Week 2, 6, and 12	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.