Demonstrated Efficacy

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

  • infammatory lesion count
  • infammatory lesion count
  • infammatory lesion count
  • infammatory lesion count

*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

ORACEA Capsules provided early and consistent inflammatory lesion reduction1

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lesion reduction chart

ORACEA Capsules demonstrate clinical efficacy equivalent to an antimicrobial dose (100 mg) of doxycycline3

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ORCA Trial

Consistent results independent of patient body weight1,2

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clinical efficacy

Consistent efficacy regardless of inflammatory lesion count at baseline2

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safety and efficacy of ORACEA

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

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

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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)

Treatment satisfaction7:

  • 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%
NAUSEA 1.3%
DIARRHEA 1.2%
HEADACHE 1.0%
Fungal infections 0.4%
Photosensitivity 0.1%
References:
  1. 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.
  2. Data on file, Galderma Laboratories, L.P.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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 words

Watch patients talk about treatment with ORACEA Capsules. SEE THE VIDEOS

What Are ORACEA Capsules?

ORACEA Capsules are the #1 rosacea brand among dermatologists

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ORACEA Capsules Tolerability

Read about the favorable tolerability profile of ORACEA Capsules

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Patient Savings

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Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.

*30 mg immediate release & 10 mg delayed release beads

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Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.

*30 mg immediate release & 10 mg delayed release beads