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 4

DISCUSSION

Results of these two pivotal studies demonstrate the efficacy and safety of topical ivermectin 1% cream in the treatment of inflammatory lesions of rosacea, emphasizing the reproducibility of this data. These results are particularly robust when considering the stringent inclusion criteria (including the high number of lesions on average at baseline) and outcome assessments (absence of erythema included in the definition of “clear”) used in these studies. At week 12, IVM 1% showed a treatment effect that was highly significant (P<.001) in all primary and secondary endpoints, with greater efficacy observed by week 4 in each study. About 40% of patients in the ivermectin group were deemed to be “clear” or “almost clear” in terms of disease severity. In addition, IVM 1% was significantly superior to vehicle as early as week 2 regard-
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