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 5
ing reduction of inflammatory lesion counts from baseline (about 75% vs 50% for vehicle in both studies).
Ivermectin was also well-tolerated and safe over the 12 week duration. The most frequent adverse reactions were skin disorders, with a lower incidence for IVM 1% than vehicle. In addition, a higher proportion of patients were observed to have no skin dryness and itching after treatment with IVM 1%, suggesting improvement of rosacea symptoms. This better tolerability profile and implied anti-inflammatory effect is consistent with the known properties of the avermectin class of drugs.8 Furthermore, patient-reported outcomes were consistent with these efficacy and safety results, with significantly more subjects treated with IVM 1% evaluating their rosacea improvement to be “good” or “excellent.” These findings are congruent with a greater proportion of IVM 1% subjects reporting improvement in general cutaneous- and also rosacea-specific quality of life measures.