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

Primary Purpose

Papulopustular Rosacea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oracea
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papulopustular Rosacea focused on measuring Papulopustular Rosacea, Oracea, anti inflammatory doxycycline

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stephens & Associates Dallas Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oracea

Arm Description

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

Outcomes

Primary Outcome Measures

Rosacea Score on the Visual Analog Scale
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable

Secondary Outcome Measures

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)
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
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.

Full Information

First Posted
March 15, 2013
Last Updated
July 28, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01872715
Brief Title
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Official Title
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
Papulopustular Rosacea, Oracea, anti inflammatory doxycycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oracea
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Oracea
Other Intervention Name(s)
doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads)
Primary Outcome Measure Information:
Title
Rosacea Score on the Visual Analog Scale
Description
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
Time Frame
Baseline, Weeks 2, 6, and 12
Secondary Outcome Measure Information:
Title
Rosacea-Specific Quality of Life Index
Description
ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)
Time Frame
Baseline, Weeks 2, 6, and 12
Title
Patient Global Assessment (PGA) of Rosacea Scores
Description
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
Time Frame
Baseline, Weeks 2, 6, and 12
Title
Patient Satisfaction Question
Description
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.
Time Frame
Week 2, 6, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stephens & Associates Dallas Research Center
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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