PMID- 25228137
OWN - NLM
STAT- MEDLINE
DCOM- 20160104
LR  - 20220408
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 172
IP  - 4
DP  - 2015 Apr
TI  - Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating 
      inflammatory lesions of rosacea: a randomized, investigator-blinded trial.
PG  - 1103-10
LID - 10.1111/bjd.13408 [doi]
AB  - BACKGROUND: Few therapeutic alternatives currently exist in the treatment of 
      papulopustular rosacea (PPR). OBJECTIVES: To demonstrate superiority of 
      once-daily ivermectin 1% cream (IVM 1%) once daily vs. twice-daily metronidazole 
      (MTZ 0.75%) cream, regarding percentage reduction of inflammatory lesions in 
      subjects with moderate to severe PPR. METHODS: In this Phase 3, 
      investigator-blinded, randomized, parallel-group study, subjects received IVM 1% 
      once daily, or MTZ 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 (AEs) and local tolerance 
      parameters. Subjects evaluated their disease following a 5-grade scale and 
      completed questionnaires. RESULTS: A total of 962 subjects were randomized to 
      receive IVM 1% (n = 478) or MTZ 0.75% (n = 484). At week 16, IVM 1% was 
      significantly superior to MTZ 0.75% in terms of reduction from baseline in 
      inflammatory lesions (83.0% vs. 73.7%; P < 0.001), observed as early as week 3 
      (Last Observation Carried Forward, LOCF). IGA results (subjects 'clear' or 
      'almost clear') also favoured IVM 1%: 84.9% vs. 75.4%, respectively (P < 0.001). 
      Incidence of AEs was comparable between groups and local tolerability was better 
      for IVM 1%. More subjects receiving IVM rated their global improvement as 
      'excellent' or 'good.' CONCLUSIONS: Ivermectin 1% cream was significantly 
      superior to MTZ 0.75% cream and achieved high patient satisfaction.
CI  - (c) 2014 British Association of Dermatologists.
FAU - Taieb, A
AU  - Taieb A
AD  - Service de Dermatologie et Dermatologie Pediatrique, Hopital Saint-Andre, 1 rue 
      Jean Burguet, 33075, Bordeaux Cedex, France.
FAU - Ortonne, J P
AU  - Ortonne JP
FAU - Ruzicka, T
AU  - Ruzicka T
FAU - Roszkiewicz, J
AU  - Roszkiewicz J
FAU - Berth-Jones, J
AU  - Berth-Jones J
FAU - Peirone, M H
AU  - Peirone MH
FAU - Jacovella, J
AU  - Jacovella J
CN  - Ivermectin Phase III study group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150211
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Dermatologic Agents)
RN  - 0 (Ointments)
RN  - 140QMO216E (Metronidazole)
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
MH  - Female
MH  - Humans
MH  - Ivermectin/*administration & dosage/adverse effects
MH  - Male
MH  - Metronidazole/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Ointments
MH  - Patient Satisfaction
MH  - Rosacea/*drug therapy
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/09/18 06:00
MHDA- 2016/01/05 06:00
CRDT- 2014/09/18 06:00
PHST- 2014/08/12 00:00 [accepted]
PHST- 2014/09/18 06:00 [entrez]
PHST- 2014/09/18 06:00 [pubmed]
PHST- 2016/01/05 06:00 [medline]
AID - 10.1111/bjd.13408 [doi]
PST - ppublish
SO  - Br J Dermatol. 2015 Apr;172(4):1103-10. doi: 10.1111/bjd.13408. Epub 2015 Feb 11.