PMID- 24595578
OWN - NLM
STAT- MEDLINE
DCOM- 20141124
LR  - 20220408
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 13
IP  - 3
DP  - 2014 Mar
TI  - Efficacy and safety of ivermectin 1% cream in treatment of papulopustular 
      rosacea: results of two randomized, double-blind, vehicle-controlled pivotal 
      studies.
PG  - 316-23
AB  - BACKGROUND: Treatments for papulopustular rosacea (PPR) are limited. OBJECTIVE: 
      To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in 
      subjects with moderate to severe PPR. METHODS: Two identically designed, 
      randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or 
      vehicle once daily for 12 weeks were conducted in subjects with moderate to 
      severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of 
      disease severity and inflammatory lesion counts. Safety assessments included 
      incidence of adverse events (AEs) and local tolerance parameters. Subjects 
      evaluated their rosacea and completed satisfaction and quality of life (QoL) 
      questionnaires. RESULTS: In both studies, a greater proportion of subjects in the 
      IVM 1% group achieved treatment success (IGA "clear" or "almost clear"): 38.4% 
      and 40.1% vs 11.6% and 18.8% for vehicle (both P<.001), respectively. Ivermectin 
      was superior to vehicle in terms of reduction from baseline in inflammatory 
      lesion counts (76.0% and 75.0% vs 50.0% for both vehicle groups, respectively). 
      For all endpoints, starting at week 4 and continuing through week 12, IVM 1% was 
      statistically significantly superior (P<.001). Fewer subjects treated by IVM 1% 
      reported dermatologic AEs, and a higher proportion of subjects were observed to 
      have no skin dryness or itching compared to vehicle. Significantly more subjects 
      receiving IVM 1% reported having an "excellent" or "good" improvement, along with 
      an improved QoL. CONCLUSION: Ivermectin 1% cream was effective and safe in 
      treating inflammatory lesions of papulopustular rosacea.
FAU - Stein, Linda
AU  - Stein L
FAU - Kircik, Leon
AU  - Kircik L
FAU - Fowler, Joseph
AU  - Fowler J
FAU - Tan, Jerry
AU  - Tan J
FAU - Draelos, Zoe
AU  - Draelos Z
FAU - Fleischer, Alan
AU  - Fleischer A
FAU - Appell, Melanie
AU  - Appell M
FAU - Steinhoff, Martin
AU  - Steinhoff M
FAU - Lynde, Charles
AU  - Lynde C
FAU - Liu, Hong
AU  - Liu H
FAU - Jacovella, Jean
AU  - Jacovella J
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 70288-86-7 (Ivermectin)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Ivermectin/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - *Quality of Life
MH  - Rosacea/*drug therapy/pathology
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/03/07 06:00
MHDA- 2014/12/15 06:00
CRDT- 2014/03/06 06:00
PHST- 2014/03/06 06:00 [entrez]
PHST- 2014/03/07 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
AID - S1545961614P0316X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2014 Mar;13(3):316-23.