IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION

EFFICACY VS METRONIDAZOLE

 

Not an actual patient
 

Proven efficacy with faster results1,2

Significantly more patients reached treatment success* with SOOLANTRA® (ivermectin) Cream, 1% vs METROCREAM® Topical Cream, 0.75%

Chart showing the percent change in mean reduction of inflammatory lesion counts over 16 weeks with SOOLANTRA at -83.0% vs. METROCREAM at -73.7% at week 16.Chart showing the percent change in mean reduction of inflammatory lesion counts over 16 weeks with SOOLANTRA at -83.0% vs. METROCREAM at -73.7% at week 16.

IGA, Investigator's Global Assessment; ITT-LOCF, intent ion-to-treat, last observation carried forward.

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA Cream once daily with METROCREAM Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.3

*Treatment success defined as ‘almost clear’ (IGA 1) or ‘clear’ (IGA 0)1,2

In a Head-to-Head Study

IGA success rate criteria3

SUCCESS RATE: the percentage of subjects with a baseline IGA score of 3 or 4 (moderate or severe) achieving an IGA score of 0 or 1 (clear or almost clear) at Week 16.3a

aIGA score was assessed before inflammatory lesion counts.5

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA® (ivermectin) Cream, 1% once daily with METROCREAM Topical Cream 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.3

Chart showing that 84.9% of patients taking SOOLANTRA were either clear or almost clear at week 16 vs. METROCREAM at 75.4%.

Superior efficacy clearance vs METROCREAM Topical Cream, 0.75%3-5,a

PERCENTAGE OF PATIENTS CLEARa AT END OF TREATMENT (WEEK 16)

Chart showing that 60% more subjects achieved an IGA score of 0 with SOOLANTRA vs. METROCREAM.Chart showing that 60% more subjects achieved an IGA score of 0 with SOOLANTRA vs. METROCREAM.

The most common adverse reactions (incident ≤1%) include skin burning and skin irritation.

aClear (IGA score of 0)=no inflammatory lesions present, no erythema.
IGA, Investigator’s Global Assessment.
84.9% of subjects were rated clear or almost clear with SOOLANTRA Cream once daily vs 75.4% with METROCREAM Topical Cream, 0.75% twice daily (P<0.001).3
A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA Cream once daily with METROCREAM Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.3

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

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. Taieb A, et al. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol. 2015;172:1103–1110. 2. Taieb A, et al. Maintenance of remission following successful treatment of papulopustular rosacea with ivermectin 1% cream vs.metronidazole 0.75% cream: 36-week extension of the ATTRACT randomized study. J Eur Acad Dermatol Venereol. 2015;829–836. 3. Taieb A, Ortonne JP, Ruzicka T, et al; lvermectin Phase III Study Group. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol. 2015;172(4):1103-1110. 4. Deeks ED. lvermectin: a review in rosacea. Am J Clin Dermatol. 2015;16(5):447-452. 5. Data on file. 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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