Clinical Photos

Visible results

with a precisely formulated non-
antibiotic dose1,2

CLINICAL PHOTOS

Treatment in action:
Before and after

With ORACEA® (doxycycline, USP) 40 mg* Capsules, you can offer your papulopustular rosacea patients an effective alternative to immediate-release doxycycline, without compromising on your ability to treat and get results1,2

*30 mg immediate release and 10 mg delayed release beads 
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 total 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) participated3

*30 mg immediate release and 10 mg delayed release beads 
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 total 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) participated3

*30 mg immediate release and 10 mg delayed release beads 
An open-label, single-center study conducted to examine patient experience with ORACEA Capsules in 20 subjects (25-70 years of age) with inflammatory lesions of rosacea. Subjects completed self-evaluation and also were evaluated by clinicians at baseline, weeks 2, 6, and 12 against multiple scales. Videos and photos were taken at time point4

*30 mg immediate release and 10 mg delayed release beads 
§A phase 4, open-label, community-based, uncontrolled trial of 1421 subjects with papulopustular rosacea. Subjects were prescribed treatment with ORACEA Capsules alone (40 mg once daily; n=826, per-protocol population)5

Sliding scale of young man face with lesions of rosacea at baseline to week 16 showing burden of roacea on his cheeks, forehead and nose then showing nearly clear skin.
Sliding scale of young man face with lesions of rosacea at baseline to week 16 showing burden of roacea on his cheeks, forehead and nose then showing nearly clear skin.
Sliding scale of woman face with lesions of rosacea at baseline to week 16 showing burden of roacea on her cheeks and nose then showing nearly clear skin.
Sliding scale of woman face with lesions of rosacea at baseline to week 16 showing burden of roacea on her cheeks and nose then showing nearly clear skin.
Sliding scale of young man face with lesions of rosacea at baseline to week 16 showing burden of roacea on his cheeks and forehead then showing nearly clear skin.
Sliding scale of young man face with lesions of rosacea at baseline to week 16 showing burden of roacea on his cheeks and forehead then showing nearly clear skin.
SUBJECTS
SUBJECT 301.5013†
SUBJECT 0174‡
SUBJECT 1010-007

clearer future

Find out how aiming for ‘CLEAR’ benefits your patients 

patient savings

Your rosacea patients may save on ORACEA Capsules

antibiotic resistance

Learn more about limiting the spread of antibiotic resistance 

EVALUATION TOOLS

INVESTIGATOR’S GLOBAL
ASSESSMENT (IGA) SCALE

Treatment Slider
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Investigator's Global Scale Assessment (IGA) Scale 4- Severe rosacea - numerous small and large papules and pustules on womans face

Severe ROSACEA

IGA 4

Numerous small and/or large papules/pustules, severe erythema

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Investigator's Global Scale Assessment (IGA) Scale 3 - Moderate rosacea numerous small and large papules and pustules on womans face

Moderate rosacea

IGA 3

Several small or large papules/pustules, moderate erythema

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Investigator's Global Scale Assessment (IGA) Scale 2 - Mild rosacea few small and large papules and pustules on womans face womans face

Mild rosacea

IGA 2

Few small papules/pustules, mild erythema

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Investigator's Global Scale Assessment (IGA) Scale 1 - Almost clear of rosacea numerous very few papules and pustules on womans faceon womans face

Almost clear of rosacea

IGA 1

Very few small papules/pustules, very mild erythema present

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Investigator's Global Scale Assessment (IGA) Scale 0 - Clear of rosacea no inflammatory lesions present, no erythema

clear of rosacea

IGA 0

No inflammatory lesions present, no erythema

  pill

Oracea capsules

See the real-world benefits of
a sub-antimicrobial dose

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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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

*30 mg immediate release and 10 mg delayed release beads

REFERENCES

1. Del Rosso JQ, et al. Two randomized phase Ill 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. Del Rosso JQ, et al. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(8):573–576. 3. Data on File. COL-101-ROSE-301 CSR. 4. Data on File. Subject 017. 5. 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(suppl 5[I]):26–36