Phase 3
N=445
Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Erythema · Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT02132117 ↗Enrolled (actual)
445
Serious AEs
1.1%
Results posted
Aug 2016
Primary outcome: Primary: Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales — 14.3; 7.4; 13.4; 4.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oxymetazoline HCL Cream 1.0% (Drug); Vehicle to Oxymetazoline HCL Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales |
14.3; 7.4; 13.4; 4.8; 15.5; 8.5 | — |
| SECONDARY Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29 |
24.1; 15.8; 24.8; 14.7; 22.0; 16.0 | — |
| SECONDARY Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29 |
-25.70; 0.00; -15.95; 2.25; -10.95; 5.15 | — |
| SECONDARY Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29 |
54.3; 34.1; 49.3; 32.3; 49.8; 33.6 | — |
| SECONDARY Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29 |
-1.8; -1.6; -1.8; -1.6; -1.8; -1.7 | — |
| SECONDARY Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1 |
29.7; 16.8 | — |
Summary
This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream 1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
Eligibility Criteria
Inclusion Criteria
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria
- Greater than 3 inflammatory lesions on the face
- Current treatment with monoamine oxidase (MAO) inhibitors
- Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Data sourced from ClinicalTrials.gov (NCT02132117). 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.