Answer Study

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Combination treatment has the potential to improve outcomes. For this study, we added Oracea® (doxycycline, USP) 40mg Capsules to Soolantra® (ivermectin) Cream, 1% to measure efficacy and ensure the treatment approach aims for 'clear'.1 Clear is defined as IGA score of 0 according to the IGA (Investigator Global Assessment) scale, which is commonly used by dermatologists.

Both molecules have independent and cooperative effects on the inflammatory pathways of rosacea.

Soolantra® (ivermectin) Cream tube and Oracea® (doxycycline, USP) Capsules bottle

Oracea® Capsules: Pivotal Study Information

Study Design

The efficacy and safety of non antibiotic dose doxycycline (40-mg doxycycline monohydrate formulated as 30-mg immediate release and 10-mg delayed release beads) for the treatment of rosacea was evaluated in 537 subjects aged > 18 years in identically designed, phase 3 trials.

 

Indication

Oracea® Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

 

Image depicting an Oracea capsule split in half showing the delayed release beads.

Study Demographics9

Table showing the subject demographics in both Study 1 and Study 2.

IGA = Investigator's Global Assessment.

Oracea Capsules Significantly Reduced Inflammatory Lesions vs Placebo2,9

Graph showing mean change in inflammatory lesion count over 16 weeks in studies 1 and 2.

8Total inflammatory lesion count = papules + pulstules.
†P=0.005;
‡P<0.001

Oracea Capsules Pivotal Studies: Safety10

Table showing AEs reported during the Oracea pivotal studies.

The most commonly reported adverse events (>2%) in patients treated with Oracea Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase.9