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Completed

NCT Number: NCT01872715

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

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

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Key information

Conditions

Papulopustular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stephens & Associates Dallas Research Center

Carrollton, Texas, 75006, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oracea

Drug

Other names: doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads)

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2013
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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