Efficacy and Safety of Ivermectin 1% Cream in Treatment of Papulopustular Rosacea: Results of Two Randomized, Double-Blind, Vehicle-Controlled Pivotal Studies

March 2014 | Volume 13 | Issue 3 | Original Article | 316 | Copyright © March 2014


Linda Stein Gold MD,a Leon Kircik MD,b Joseph Fowler MD,c Jerry Tan MD,d Zoe Draelos MD,e Alan
Fleischer MD,f Melanie Appell MD,g Martin Steinhoff MD,h Charles Lynde MD,i
Hong Liu MSc,j and Jean Jacovella MDk
on behalf of the Ivermectin Phase III Study Group

aHenry Ford Medical Center, Department of Dermatology, Detroit, MI
bDerm Research, PLLC, Louisville, KY
cDermatology Specialists Research, Louisville, KY
dWindsor Clinical Research, Inc., Windsor, ON, Canada
eDepartment of Dermatology, Duke University School of Medicine, Durham, NC
fDepartment of Dermatology, Wake Forest University Health Sciences, Winston, Salem, NC
gTotal Skin and Beauty Dermatology Center, PC, Birmingham, AL
hUniversity of California-San Francisco, San Francisco, CA
iLynderm Research, Inc., Markham, ON, Canada
jGalderma R&D, Cranbury, NJ
kGalderma R&D, Sophia Antipolis, France

table 3
with rosacea, especially mild or moderate dry skin (for Studies 1 and 2, 63.0% and 57.0% for IVM 1%, and 59.3% and 60.0% for vehicle, respectively) and mild or moderate itching (57.3% and 49.4% for IVM 1%, and 45.4% and 49.1% for vehicle). At week 12 (last available data observed), the majority of subjects had none of the 3 cutaneous symptoms. A trend was observed in terms of absence of dryness in 83-86% of IVM 1% subjects vs 72-76% for vehicle, as well as for absence of itching in 82-85% for IVM 1% vs 70-78% for vehicle.

Patient-Reported Outcomes

Improvement after treatment was rated by subjects as “excellent” or “good” by 69% and 66.2% for IVM 1% compared to 38.6% and 34.4% for vehicle (P<.001), respectively (Figure 4).“Excellent” improvement was reported by 34.3% and 32.0% for IVM 1% vs 9.5% and 7.3% for vehicle.
After 12 weeks of treatment, improved QoL scores were observed for subjects in the IVM 1% compared to vehicle groups. For the DLQI, it is of note that no difference between treatment groups was observed at baseline. At the end of each study, more subjects in the IVM 1% group (about 53%) than vehicle (about 35%) considered that their disease had no effect on their overall QoL (P<.001). For RosaQoL ™, improvement in QoL from baseline was higher in both studies for IVM 1% (-0.64 ± 0.7 and -0.60 ± 0.6 vs -0.35 ± 0.5 for both vehicle groups (P<.001 and P=.001 for Studies 1 and 2, respectively).