Phase 4
N=24
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT01872715 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Rosacea Score on the Visual Analog Scale — 4.50; 4.52; 3.77; 3.06 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oracea (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rosacea Score on the Visual Analog Scale |
4.50; 4.52; 3.77; 3.06 | — |
| SECONDARY Rosacea-Specific Quality of Life Index |
3.34; 3.07; 2.89; 2.85 | — |
| SECONDARY Patient Global Assessment (PGA) of Rosacea Scores |
0; 1; 17; 4; 0; 0 | — |
| SECONDARY Patient Satisfaction Question |
1; 11; 8; 2; 0; 4 | — |
Summary
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.
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
Data sourced from ClinicalTrials.gov (NCT01872715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.