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

July 28, 2022 updated by: Galderma R&D
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Carrollton, Texas, United States, 75006
        • Stephens & Associates Dallas Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Oracea
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
Time Frame: Baseline, Weeks 2, 6, and 12
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
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)
Baseline, Weeks 2, 6, and 12
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
Baseline, Weeks 2, 6, and 12
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.
Week 2, 6, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLI.04.SPR.US10233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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