Soolantra® Cream: Pivotal Study Information
The efficacy and safety of SOOLANTRA® (ivermectin) Cream, 1% QD* was evaluated in 1371 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 shown5,6
- Superior Efficacy to MetroCream Topical Cream, 0.75%
- SOOLANTRA Cream has a higher IGA success rate** in clinical trials3,7
- 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)7
- 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)8
- A Phase 3, investigator‑blinded, multicenter, randomized, parallel‑group study comparing 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 irritation4,7
- 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).