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

Two weeks in and I have already started to see a noticable improvement with my rosacea bumps and blemishes†

Woman with rosacea.

Not an actual patient

†Individual results may vary

ANSWER Study Overview11

Study Objective

Evaluate efficacy of ORACEA Capsules plus SOOLANTRA Cream vs SOOLANTRA Cream alone in severe rosacea with papulopustular lesions

 

Design

Multicenter, randomized, investigator-blinded, parallel-group comparison, 12-week study

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

Image outlining the ANSWER Study design.

†Subjects were provided with non-investigational products, that they were required to use alongside their treatments for the duration of the study. These products were Cetaphil Redness Relieving Foaming Face Wash and Cetaphil Redness Relieving Facial Moisturizer SPF 30.
IGA = Investigator's Global Assessment.

Baseline Characteristics

Patients in two groups were well-ballanced in terms of demographics, skin phototype and severity and duration of disease.

Baseline demographic data11

Table showing the baseline demographic data for the ANSWER Study.

SD=standard deviation.

Baseline disease characteristics11

Table showing the baseline disease characteristics in the ANSWER Study.

Primary Endpoint

Percentage change from baseline in inflammatory lesion counts at week 12.

Safety Data

The combination of SOOLANTRA Cream + ORACEA Capsules treatment resulted in no discontinuations of treatment due to related AEs.

Dual Therapy Demonstrates a Significant Reduction in Inflammatory Lesions from Baseline vs. Monotherapy at Week 1211

Graph showing the mean percentage reduction in IL through week 12. At week 12, dual therapy had an 80.29% mean inflammatory lesion reduction vs. SOOLANTRA Cream + placebo at 73.56%.

Baseline: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138); Week 12: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138)
ITT/LOCF = intention to treat/last observation carried forward.

Dual Therapy Significantly Increased the Percentage of Subjects Achieving 100% Reduction of Inflammatory Lesions by Week 1211

Graph showing that 2x as many subjects on combination therapy achieved 100% lesion reduction vs. monotherapy.

Baseline: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138); Week 12: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138)

66.7% of Subjects (All IGA 4) Achieved Clear/Almost Clear (IGA 0 or 1) With Dual Therapy at Week 1211

Graph showing that 66.7% of patients using combination treatment achieved clear/almost clear at 12 weeks vs. monotherapy at 59.4%.

Baseline: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138); Week 12: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138)

 

Treatment-Related Adverse Events Were Similar in the Two Treatment Arms11

Table showing AEs reported during the ANSWER Study.

In clinical trials with SOOLANTRA Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation. 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.

*Subjects with at least one event from baseline to end of study. Numbers in columns cannot be added because a given subject may have reported more than one AE.

 

DLQI Scores Improved for Both Physiological and Psychological Symptoms at Week 12 for Both Treatment Arms2

Chart showing DLQI (dermatology life quality index) score improvement specifically in itchiness, soreness, painfulness, stinging, embarrassment, and self consciousness in the ANSWER Study.

Baseline:IVM + DMR n=135 IVM + PBO n=138; Week 12 IVM + DMR n=125 IVM + PBO n=129 DLQI, dermatology life quality index;
DMR, doxycycline modified release; IVM, ivermectin; PBO, placebo

 

Both Treatment Regimens Resulted in High Patient Satisfaction11

Table showing patient satisfaction percentages in the ANSWER Study.

Week 12: SOOLANTRA Cream + ORACEA Capsules (n=125), SOOLANTRA Cream + Placebo (n=129)

 

Before/After

Image showing real patients' lesion reduction from baseline to week 12 in the ANSWER Study.

RETURN TO EFFICACY

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.

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

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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