Soolantra® Cream: Pivotal Study Information
The efficacy and safety of Soolantra (ivermectin) Cream, 1% QD* was evaluated in 1,371 subjects aged ≥18 years in 2 identically designed phase 3 trials. Final results were comparable between the 2 studies, with the least-favorable results presented here.2,3
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).