In a relapse study
, researchers report successful initial treatment with once-daily ivermectin 1% cream (Soolantra, Galderma) resulted in longer remission among patients with moderate-to-severe papulopustular rosacea
, compared with initial treatment with twice daily metronidazole 0.75% cream.
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Papulopustular rosacea remission is known to be challenging to maintain post treatment. Patients in the two groups studied were successfully treated for 16 weeks with either Ivermectin 1% cream or metronidazole 0.75% cream. The data in the new study (Part B) looks at a 36-week extension of the phase 3 ATTRACT (Assessment of a Topical Treatment in Rosacea: Activity, Compliance, Tolerability) superiority study (Part A), published in the British Journal of Dermatology
For the new study, researchers followed rosacea patients every four weeks for up to 36 weeks. Among the findings: Median time to first relapse was 115 days in the ivermectin 1% group, versus 85 days in the metronidazole 0.75% arm. Relapse rates at the end of the study were 62.7% treated with ivermectin, versus 68.4 percent metronidazole. And the median number of days free of treatment was 196 days in the ivermectin arm, compared to 169.5 days metronidazole
Adverse events were equally low in both arms, according to the study.
Dermatologist Hilary Baldwin, M.D., medical director at the Acne Treatment and Research Center and a Galderma consultant, tells Dermatology Times
that new data showing longer time to relapse and more days free of medication for patients successfully treated with once daily Soolantra Cream versus those treated with twice daily metronidazole addresses “real world” human nature.
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“Knowing that rosacea is a chronic condition, long-term suppression of the inflammatory process is to the benefit of the patient,” Dr. Baldwin says. “So I always encourage my patients to remain on their treatment, even when their symptoms improve — reminding them it is not about how they look tomorrow, or a week from now, but five or 10 years down the road. However, we know in real-world practice, patients aren’t always going to remain compliant in drug application, especially when their symptoms are better. Based on the findings of the long term phase 3 ATTRACT study, the benefit of using Soolantra Cream is that it extends remission longer than metronidazole, giving patients the opportunity to take a ‘drug holiday’ from their prescription, without necessarily losing any progress with their treatment.”
Dr. Baldwin says that she anticipated using ivermectin 1% cream as an adjunctive therapy to Oracea (doxycycline, USP 40 mg, Galderma) for patients with severe papulopustular rosacea. However, while she often uses the medications together, she now also uses Soolantra Cream as a standalone treatment with positive results.
“Therefore, now I often let the patient decide between an oral or topical treatment, given the strong safety and efficacy profiles seen in both Oracea and Soolantra. I find that if the patient is part of the decision, they tend to have better compliance with their medication,” she says.
According to Dr. Baldwin, anyone with papulopustular rosacea is an eligible candidate for Soolantra Cream, regardless of severity.
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“Mild, moderate or severe, Soolantra works well to reduce inflammatory lesions — though not studied in erythematotelangiectatic rosacea. Patients with really sensitive skin, or those who do not like to take oral medications, are very good candidates for Soolantra Cream,” Dr. Baldwin says.
Dr. Baldwin says that she has not heard any patients in her practice complain of side effects from the Soolantra cream.
“In fact, Soolantra Cream was specifically designed to be gentle on the skin, using Cetaphil as the basis for the vehicle, which is important to rosacea patients who often have sensitive skin,” she says. “In clinical trials, side effects were infrequent and mild, with the most common including skin burning sensation and skin irritation. Proper use of any prescription treatment is critical in managing side effects.”