Skip to main content

A multicenter, randomized, outpatient, double-blind, placebo-controlled, parallel-group trial was conducted over 16 weeks to evaluate the safety and efficacy of ORACEA Capsules. A totaI of 251 subjects (≥18 years of age with 10 to 40 papules and pustules and <2 nodules, plus an Investigator Global Assessment [IGA] score of 2 to 4) participated10

Powerful results as early as week 3 with continued improvement through week 16 vs placebo.1,2*

In pivotal clinical studies, the most common treatment-related adverse events (>2%) for ORACEA Capsules were nasopharyngitis (4.8%), diarrhea (4.5%), hypertension (3%), sinusitis (2.6%), and aspartate aminotransferase increase (2.2%).

*A multicenter, outpatient, double-blind, placebo-controlled, paralleI-group triaI was conducted over 16 weeks to evaluate the safety and efficacy of ORACEA Capsules. A total of 251 rosacea subjects (18 years of age with 10 to 40 papules and pustules and 2 nodules, plus an IGA score of 2 to 4) participated1
30 mg immediate release and 10 mg delayed release beads

Powerful results your patients can see

Fast onset of action with significant reduction in inflammatory lesions at week 163*

In pivotal clinical studies, the most common treatment-related adverse events (>2%) for ORACEA Capsules were nasopharyngitis (4.8%), diarrhea (4.5%), hypertension (3%), sinusitis (2.6%), and aspartate aminotransferase increase (2.2%).

*A randomized, multicenter, outpatient, double-blind, active-controlled, noninferiority trial of 91 rosacea subjects (18 years of age) for 16 weeks.
Patients were prospectively randomized to receive daily doses of either ORACEA Capsules or doxycycline (100 mg), each in combination with metronidazole cream, 1%3
30 mg immediate release and 10 mg delayed release beads
LOCF, last observation carried forward

Oracea® 40 mg* Capsules provide consistent results across different BMI ranges and baseline lesion counts5

Consistent results independent of patient body weight and number of lesions

Post-hoc analysis of data from a multicenter, double-blind, placebo-controlled trial, which was conducted over 16 weeks to evaluate the safety and efficacy of ORACEA Capsules. The subgroup analysis was based on pooled data from 2 Phase 3 trials to evaluate the impact of weight on efficacy for ORACEA Capsules in reducing inflammatory lesions.1,3

In pivotal clinical studies, the most common treatment-related adverse events (≥2%) were nasopharyngitis (4.8%), diarrhea (4.5%), hypertension (3%), sinusitis (2.6%) and aspartate aminotransferase increase (2.2%).1

Trial: A large-scale, Phase 4 trial in papulopustular rosacea
 

ORACEA Capsules were proven effective in the largest community rosacea trial to date6

In the ORCA (ORACEA Capsules for Rosacea: a Community-based Assessment) Trial:

  • Monotherapy with ORACEA Capsules (n=1,196)7: 74.6% of subjects were clear or near clear by week 12 (n=826 per-protocol population)

Treatment satisfaction:7

  • 90.4% of the community-based investigators reported they were likely or very likely to continue prescribing ORACEA Capsules
  • 81.3% of subjects were satisfied or very satisfied with ORACEA Capsules as monotherapy
  • 79.3% of subjects were satisfied or very satisfied with ORACEA Capsules as add-on therapy