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Soolantra Cream Pivotal Studies: Subject Demographics**

SD=standard deviation. QD=once daily.
*Subjects were instructed to apply once daily every day at bedtime.
**Data shown are from one of two pivotal trials.

Higher IGA Success Rate With Soolantra Cream vs. Vehicle Cream at Weeks 4, 8 and 12 in Two Pivotal Studies2,3

Greater Inflammatory Lesion Reduction With Soolantra Cream vs. Vehicle Cream at Weeks 2, 4, 8 and 12 in Pivotal Studies2,3

Inflammatory lesion count continued to improve throughout the study
The most common adverse reactions (incidence ≤ 1%) included skin-burning sensation and skin irritation

Soolantra Cream Long-Term Safety Study: Treatment Related AEs4**

A greater percentage of subjects on vehicle/azelaic acid had treatment related AEs vs. subjects using Soolantra Cream.
No severe or serious AEs were considered related to Soolantra Cream or AzA.
Five subjects in Soolantra Cream group and 4 subjects in the AzA group discontinued from the study due to an AE during Part B. None of the AEs that led to discontinuation in the Soolantra Cream group were considered related to Soolantra Cream.
**A subject was counted once, even if the subject experienced more than 1 AE during the study.

 

 

With Soolantra Cream, Clearer Is Possible!

  • Proposed Dual MOA of Ivermectin*
    • Anti-inflammatory and anti-parasitic activity of ivermectin has been shown
  • Superior Efficacy to MetroCream Topical Cream, 0.75%
    • Soolantra Cream has a higher IGA success rate** in clinical trials
    • 84.9% of Soolantra Cream-treated subjects achieved IGA success vs. 75.4% of MetroCream Topical Cream, 0.75%-treated subjects at week 16 (P < 0.001)
    • 60% more subjects became clear (IGA = 0) with Soolantra Cream vs. MetroCream Topical Cream, 0.75%
    • 33% more subjects treated with Soolantra Cream did not need retreatment (subjects were observed every 4 weeks from week 16 to week 52)
    • A phase 3, investigator-blinded, multicenter, randomized, parallel-group study compring the efficacy and safety of Soolantra Cream once daily with MetroCream 0.75% twice daily in 962 subjects 18 years or older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.
  • Highly Tolerable
    • Soolantra Cream was safe and well tolerated
    • Soolantra Cream was better tolerated than azelaic acid 15% gel and MetroCream Topical Cream, 0.75%
    • Soolantra Cream is safe for up to 52 weeks of treatment
    • In clinical trials, the most common related adverse reactions with Soolantra Cream (incidence ≤1%) included skin-burning sensation and skin irritation
    • Soolantra Cream utilizes Cetaphil Moisturizing Cream as the basis for the vehicle
    • No severe or serious AEs were considered related to Soolantra Cream or AzA.

*The mechanism of action of Soolantra Cream in treating rosacea lesions is unknown.
**IGA success was defined as IGA score of 0 (clear) or 1 (almost clear).

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