Galderma has launched Soolantra, a topical cream containing 10mg/g ivermectin. Soolantra is indicated for the topical treatment of inflammatory lesions of papulopustular rosacea in adults.
The cream should be applied to the face once daily for up to 4 months. Pea-sized amounts are applied to the forehead, chin, nose and both cheeks, and then spread as a thin layer across the entire face, avoiding the eyes, lips and mucosa. If there is no improvement after 3 months, application of the cream should be stopped. The treatment course may be repeated if required.
Ivermectin has anti-inflammatory effects by inhibiting production of inflammatory cytokines. It also causes death of parasites by binding to chloride channels in invertebrate nerve and muscle cells. This may be relevant to the mode of action of ivermectin in rosacea as Demodex mites may have a role in skin inflammation.
Two randomised, double-blind, vehicle-controlled trials of identical design (total n=1371) showed that topical ivermectin 10mg/g cream is effective in the treatment of moderate to severe papulopustular rosacea.
After 12 weeks of once-daily treatment, patients randomised to ivermectin had higher rates of treatment success (defined as ‘clear’ or ‘almost clear’ on the Investigator’s Global Assessment [IGA] of disease severity) than those assigned to vehicle cream (38.4% and 40.1% vs 11.6% and 18.8%, p<0.001).
Inflammatory lesion counts, the other co-primary endpoint, were also reduced to a greater extent with ivermectin than with vehicle (76.0% and 75.0% vs 50.0% and 50.0%, p<0.001).
The effect of ivermectin on both endpoints was significant from week 4.
In a 40-week extension of the studies, the proportion of ivermectin-treated patients who achieved treatment success continued to increase up to week 52.
Superior to metronidazole
Ivermectin 10mg/g cream was compared with metronidazole 7.5mg/g cream (administered twice daily) in a randomised, investigator-blinded study in 962 patients with moderate to severe papulopustular rosacea.
Once-daily ivermectin produced greater reductions than metronidazole in inflammatory lesion counts after 16 weeks’ treatment (83.0% vs 73.7%, p<0.001). Treatment success rates, as determined by IGA, were also higher with ivermectin: 84.9% vs 75.4% (p<0.001).
The most common side-effects of topical ivermectin—skin burning sensation, skin irritation, pruritus and dry skin—occur in 1% or less of patients. They are usually mild to moderate in severity and tend to diminish with continued treatment.