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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

  • Drug: Oracea

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Rosacea-Specific Quality of Life Index
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor

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