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

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

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

Conditions
-----------------
Papulopustular Rosacea

Intervention / Treatment
-----------------
* Drug: Oracea


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oracea<br>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 | Drug: Oracea<br> <br> * Other names: doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Papulopustular Rosacea, Oracea, anti inflammatory doxycycline