A combination treatment of 1% ivermectin (IVM) cream and 40 mg doxycycline modified-release (DMR) capsules is associated with improved and faster response rates and increased treatment satisfaction compared with IVM monotherapy in patients with severe rosacea, according to study results published in the Journal of the American Academy of Dermatology.
Patients with severe rosacea were randomly assigned (1:1) to either IVM plus DMR combination therapy (n=135) or IVM monotherapy plus placebo (n=138). All participants were recruited from 39 sites across the United States, Canada, and Europe. During the 12-week study period, patients applied IVM once-daily in the evening and took either DMR or placebo once a day. The percentage change from baseline to week 12 in inflammatory lesion count comprised the primary study end point. Researchers also examined changes in stinging and burning, global improvements, and flushing count per week.
At 12-week follow-up, patients randomly assigned to the IVM plus DMR combination group demonstrated greater reductions in inflammatory lesions compared with the monotherapy group (−80.3% vs −73.6%, respectively; P =.032). In addition, the combination arm had a greater change in the Investigator’s Global Assessment score (P =.032). Treatment with IVM and DMR was also associated with an increase in the number of patients who achieved IGA 0 (“clear”) during the study period (11.9% vs 5.1%; P =.043), as well as a 100% reduction in lesions (17.8% vs 7.2%; P =.006). The combination regimen, as well as the monotherapy regimen, resulted in similar reductions in the Clinician’s Erythema Assessment score, stinging/burning, flushing episodes, and Dermatology Life Quality Index and ocular signs/symptoms.
Study limitations include the relatively small sample size, short study duration, and the lack of a pure placebo control group.
“In conclusion,” the researchers wrote, “these study results suggest that using a combination of IVM and DMR, each once daily, along with a properly selected skin care regimen, can improve treatment results.”
Schaller M, Kemeny L, Havlickova B, et al. A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40 mg modified-release capsules versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea [published online May 28, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.05.063