Once-Daily Ivermectin Safe and Effective Rosacea Treatment

Lara C. Pullen, PhD

March 31, 2015

Ivermectin cream 1% (Soolantra, Galderma Labs) is significantly more effective than metronidazole cream 0.75% in the treatment of papulopustular rosacea, according to a new study.

The results reinforce the fact that "this novel treatment can help fill an important unmet need for patients who struggle with the inflammatory lesions of rosacea," Linda Stein Gold, MD, from the Henry Ford Hospital in Detroit, told Medscape Medical News.

The study results were presented during a poster session at the American Academy of Dermatology 73rd Annual Meeting in San Francisco.

Papulopustular rosacea — a chronic inflammatory condition that affects the face, causing excessive flushing, redness, bumps, and pus pimples — continues to be a therapeutic challenge.

"In a national study of rosacea patients, 46% of sufferers reported that they changed their medication, usually due to lack of improvement," Dr Stein Gold reported.

The team conducted a phase 3, investigator-blinded, randomized trial at 64 centers in 10 European countries.

The 962 patients were randomized, for 16 weeks, to once-daily treatment with ivermectin cream 1% or to twice-daily treatment with metronidazole 0.75% cream.

At baseline, the two groups were comparable; patients had a mean of 32 inflammatory lesions and the majority of patients had moderate rosacea. The study was completed by 93.8% of the cohort.

The reduction in inflammatory lesions in the ivermectin group was significant.

Table. Mean Reduction in Inflammatory Lesions From Baseline

Time Ivermectin Cream, % Metronidazole Cream, % P Value
Week 3 32.5 30.5 <.05
Week 6 55.6 49.2 <.001
Week 9 66.3 59.8 <.001
Week 12 75.7 67.1 <.001
Week 16 83.0 73.7 <.001

 

In addition, significantly more patients achieved an Investigator's Global Assessment score of 0 or 1, indicating clear or almost clear, in the ivermectin group than in the metronidazole group (84.9% vs 75.4%).

And more patients in the ivermectin group than in the metronidazole group rated their global improvement as "excellent to good" (85.5% vs 74.8%).

"We're not looking at a huge difference," Charles Johnston, MD, from Facets Private Healthcare Group in Oak Park, Illinois, told Medscape Medical News. "Does the patient really notice a difference?" he asked.

The safety profile of the two agents is comparable, but ivermectin has better local tolerability than metronidazole, the investigators report.

"Topical ivermectin is a new topical therapy with proven efficacy for the bumps and pus pimples of rosacea, and likely works by reducing Demodex on the skin," said Joshua Zeichner, MD, from Mount Sinai Medical Center in New York City.

"Demodex mites live on everyone's skin, but exist in higher numbers on the skin of rosacea patients. Moreover, in rosacea, the skin is hypersensitive to these mites. Treatment of rosacea includes reducing skin inflammation and lowering mite colonization," he explained.

"Although we don't quite understand the pathogenesis of rosacea, there seems to be a role for topical antiparasitic drugs such as ivermectin in papulopustular rosacea treatment," Anne Chapas, MD, also from Mount Sinai, told Medscape Medical News.

"In this study, ivermectin cream showed a slight superiority to the gold standard topical treatment of metronidazole cream, and patients seemed to prefer its overall improvement and simple once a day dosing," she added.

This study was funded by Galderma Research and Development. Dr Stein Gold is an advisor, investigator, and speaker for Galderma Laboratories. Dr Zeichner has served as an advisory board member and consultant for Galderma. Dr Chapas is a trainer for Galderma. Dr Johnston has disclosed no relevant financial relationships.

American Academy of Dermatology (AAD) 73rd Annual Meeting: Abstract 1158. Presented March 21, 2015.

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