Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01872715
Recruitment Status : Completed
First Posted : June 7, 2013
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

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

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: Oracea Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872715


Locations
Layout table for location information
United States, Texas
Stephens & Associates Dallas Research Center
Carrollton, Texas, United States, 75006
Sponsors and Collaborators
Galderma Laboratories, L.P.

Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01872715     History of Changes
Other Study ID Numbers: GLI.04.SPR.US10233
First Posted: June 7, 2013    Key Record Dates
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016
Last Verified: January 2016

Keywords provided by Galderma Laboratories, L.P.:
Papulopustular Rosacea
Oracea
anti inflammatory doxycycline

Additional relevant MeSH terms:
Layout table for MeSH terms
Rosacea
Skin Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents