ORACEA® Capsules are the only FDA-approved oral therapy for the papules and pustules (inflammatory lesions) of rosacea
- ORACEA Capsules have anti-inflammatory activity with no evidence of antimicrobial effect in a convenient, once-daily dose1
- In clinical studies, results started as early as week 3 and improvement continued through week 161
Before and After ORACEA Capsules in Clinical Trials
*Individual results may vary
A multicenter, outpatient, double-blind, placebo-controlled, parallel-group trial was conducted over 16 weeks to evaluate the safety and efficacy of ORACEA Capsules. A total of 251 rosacea patients (≥18 years of age with 10 to 40 papules and pustules and ≤2 nodules, plus an IGA score of 2 to 4) participated.1
Favorable tolerability profile vs doxycycline 100 mg3
- In this head-to-head clinical study, no nausea, diarrhea, or vomiting were reported for ORACEA Capsules (17%, 4.3%, and 4.3% for doxycycline 100 mg)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%).2
Proven effective in the largest community rosacea trial to date4
In the ORCA (ORACEA for Rosacea: a Community-based Assessment) Trial:
- Monotherapy with ORACEA Capsules (n=1,196)5: 74.6% of subjects were clear or near clear by week 12 (n=826 per-protocol population)
- Doxycycline as add-on therapy (n=224)6: 75.7% of subjects were clear or near clear by week 12 (n=140 per-protocol population)
- 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
The most commonly reported treatment-related AEs in subjects treated with ORACEA Capsules as monotherapy in the ORCA trial were mild to moderate and included5:
|Skin and subcutaneous tissue disorders||2.7%|
- Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791-802.
- Data on file, Galderma Laboratories, L.P.
- Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573-576.
- Del Rosso JQ. The ORCA (Oracea for rosacea: a community-based assessment) trial: a large-scale, phase 4 trial in papulopustular rosacea. Cutis. 2010;86(5 Suppl):4-6.
- Webster GF. An open-label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads). Cutis. 2010;86(5 Suppl):7-15.
- Del Rosso JQ. Effectiveness and safety of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) once daily as add-on therapy to existing regimens for the treatment of papulopustular rosacea: results from a community-based trial. Cutis. 2010;86(5 Suppl):16-25.
- Baldwin HE. A community-based study of the effectiveness of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) on quality of life and satisfaction with treatment in participants with rosacea. Cutis. 2010;86(5 Suppl):26-36.
In their own wordsWatch patients talk about treatment with ORACEA Capsules. SEE THE VIDEOS
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