Few therapeutic alternatives currently exist in the treatment of papulopustular rosacea.
The aim of a study was to demonstrate superiority of once-daily Ivermectin ( Efacti; Soolantra ) 1% cream once daily versus twice-daily Metronidazole 0.75% cream, regarding percentage reduction of inflammatory lesions in subjects with moderate to severe papulopustular rosacea.
In this phase 3, investigator-blinded, randomized, parallel-group study, subjects received Ivermectin 1% once daily, or Metronidazole 0.75% twice daily over 16 weeks.
Efficacy assessments were inflammatory lesion counts and Investigator's Global Assessment ( IGA ). Safety assessments included incidence of adverse events and local tolerance parameters.
Subjects evaluated their disease following a 5-grade scale and completed questionnaires.
A total of 962 subjects were randomized to receive Ivermectin 1% ( n=478 ) or Metronidazole 0.75% ( n=484 ).
At week 16, Ivermectin 1% was significantly superior to Metronidazole 0.75% in terms of reduction from baseline in inflammatory lesions ( 83.0% vs 73.7%; P less than 0.001 ), observed as early as week 3 ( Last Observation Carried Forward, LOCF ).
IGA results ( subjects clear or almost clear ) also favoured Ivermectin 1%: 84.9% vs 75.4%, respectively ( P less than 0.001 ).
Incidence of adverse effects was comparable between groups and local tolerability was better for Ivermectin 1%. More subjects receiving Ivermectin rated their global improvement as excellent or good.
In conclusion, Ivermectin 1% cream was significantly superior to Metronidazole 0.75% cream and achieved high patient satisfaction. ( Xagena )
Taieb A et al, Br J Dermatol 2015;172:1103-1110