IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION

Answer Study

 

Not an actual patient
 

Let's clear up the facts

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

Knowing there is an innovative treatment available to keep my rosacea bumps and blemishes under control is really encouraging and exciting†

Woman with rosacea.

Not an actual patient

†Individual results may vary

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.

*Total 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.

In this clinical study, the most common treatment-related adverse events (:>4%) for ORACEA capsules were diarrhea, nausea, coated tongue, vomiting, and photosensitivity.9

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Important Safety Information

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Not for oral, ophthalmic or intravaginal use. Adverse Events: In clinical trials with SOOLANTRA Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.

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.

References: 1. Webster G, et al. Defining treatment success in rosacea as ‘clear’ may provide multiple patient benefits:results of a pooled analysis. J Dermatology Treat. 2017; 4: 1–6. 2. Data on file. Galderma Laboratories, L.P. 3. Stein Gold L, et al. J Drugs Dermatol. 2014;13(3):316–323. 4. Stein Gold L, et al. J Drugs Dermatol. 2014;13(11):1380–1386. 5. Ci X, et al. Fundam Clin Pharmacol. 2009;23:449–455. 6. SchallerM, et al. J Eur Acad Dermatol Venereol. 2017;31(11):1907–1911. 7. Taieb A, et al. Br J Dermatol. 2015;172(4):1103–1110. 8. TaiebA, et al. J Eur Acad Dermatol Venereol. 2016;30(5):829–836. 9. Del Rosso JQ, et al. J Am Acad Dermatol. 2007;56:791–802. 10. Oracea [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P., 2014. 11. Data on file. Study #113322. Fort Worth, TX; Galderma Laboratories, L.P.

See Important Safety Information

IMPORTANT SAFETY INFORMATION

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Adverse Events: In clinical trials with SOOLANTRA® Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.
Warnings / Precautions: Not for oral, ophthalmic or intravaginal use.

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.

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