Phase 3
N=92
Patient-Reported Outcome Of Facial Erythema (PROOF)
Rosacea · Erythema
Bottom Line
View on ClinicalTrials.gov: NCT01885000 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment — 69.6; 40.4 Percentage of participants — p== 0.0065
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brimonidine tartrate was applied cutaneously once daily for 8 days. (Drug); Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment |
69.6; 40.4 | = 0.0065 sig |
| PRIMARY Percentage of Participants With Facial Redness Questionnaire at Day 8 |
45.7; 69.0; 54.3; 31.0; 47.9; 59.5 | = 0.0328 sig |
| PRIMARY EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8 |
95.7; 92.9; 4.3; 7.1; 97.8; 97.6 | = 0.5821 |
| PRIMARY Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8 |
-15.4; -32.6 | = 0.3935 |
| PRIMARY Euro Quality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along With a Visual Analogue Score for the Overall Health State) at Day 8 |
76.0; 80.2 | = 0.4162 |
| SECONDARY Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA) |
47.8; 7.1 | — |
| SECONDARY Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment |
41.3; 23.8 | — |
| SECONDARY Change From Baseline in Facial Inflammatory Lesion Counts at Day 8 |
0.3; 0.4 | — |
| SECONDARY Number of Participants Reported Adverse Events |
15; 9 | — |
Summary
The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects age of 18 years or older
- A clinical diagnosis of facial rosacea
- A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug application
- A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application
Exclusion Criteria
- More than 5 facial inflammatory lesions (papules or pustules) of rosacea
- Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator
- Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure)
- Female who is pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT01885000). 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.