Linda F. Stein Gold, MD, Director of Dermatology Research at Henry Ford Health System, Detroit, MI, has many years of clinical and research experience in the treatment of patients with skin disorders. She spoke with American Health & Drug Benefits about the current status of the treatment of patients with rosacea, suggesting that new treatments currently in late development are expected to improve outcomes.
Q: How satisfied are dermatologists and patients with the current treatments for papulopustular rosacea?Dr Stein Gold: Topical azelaic acid and metronidazole are good treatments for rosacea, but they are not enough for all patients. We need better options that get patients’ rosacea under control even more quickly, and treatments that are better tolerated, especially in our patients with more severe rosacea.
Q: What is your greatest challenge as a dermatologist in trying to treat rosacea?Dr Stein Gold: I think the biggest unmet need for our patients with papulopustular rosacea is to have safe and effective treatments that have lasting results. It is important for patients to have treatment options that produce durable effects that will last even after the treatment is discontinued.
Q: What could be added to the treatment arsenal that might benefit all or a subset of patients?Dr Stein Gold: Topical ivermectin, which is under consideration by the US Food and Drug Administration, is an anti-inflammatory and antiparasitic agent that eliminates the Demodex folliculorum skin mite that is believed to be one of the underlying causes of rosacea. Ivermectin offers dermatologists a new treatment option that is effective even for our patients with severe rosacea. It was very well tolerated in clinical trials, which is critical for these patients, because they are often sensitive to topical agents. In addition, we are seeing a durable effect that may offer patients a “drug holiday,” namely, time off from treatment. Patients may be able to have lasting effects even after treatment is discontinued, and the fear of immediate relapse may be allayed.
Q: Could you comment on the findings from the phase 3 trials of ivermectin 1% cream, for which you were a lead investigator?Dr Stein Gold: In the phase 3 trials, patients with moderate-to-severe rosacea were evaluated in 2 identical studies conducted at the same time. Patients received ivermectin 1% cream or vehicle cream once daily for 12 weeks. One criterion for treatment success was defined as the disease being “clear” or “almost clear” at week 12 according to the Investigator’s Global Assessment (IGA) scale. The results for Study 1 showed a significant difference between ivermectin and the vehicle cream as early as week 4. By week 12, 38.4% of patients achieved IGA success compared with 11.6% of patients who received the vehicle cream.
Study 2 showed a similar pattern, with a significant difference between the 2 groups by week 4, which was maintained at week 12. At week 12, a 40.1% IGA success rate was seen with ivermectin versus 18.8% with the vehicle cream. We are seeing reliability and reproducibility between the studies.
We need to be careful with any topical agents used by patients with rosacea, because many of our patients have very sensitive skin. The vehicle, Cetaphil, was well tolerated, and I was surprised to see how well tolerated the ivermectin also was in the clinical trials. In fact, patients in the ivermectin arm of Study 1 had a lower incidence of local side effects than did the patients in the vehicle alone arm—4.2% versus 7.8%, respectively.
Q: How does ivermectin work differently from current treatments?Dr Stein Gold: Ivermectin has 2 possible mechanisms of action. First, we know that it has anti-inflammatory properties. Second, we know that it is an antiparasitic agent effective against D folliculorum. Demodex are present in increased concentrations in patients with rosacea, and we believe that the Demodex, or the bacteria associated with these skin mites, exacerbate rosacea and contribute to the inflammation.
Q: What is your main message to dermatologists and payers regarding the treatment of rosacea?Dr Stein Gold: This is an exciting time for the treatment of patients with rosacea. We hope to soon have a new treatment option that is fast-acting, effective, and very well tolerated, even for our patients with more severe rosacea.