title: Maintenance of remission following successful treatment of papulopustular rosacea with ivermectin 1% cream vs. metronidazole 0.75% cream: 36-week extension of the ATTRACT randomized study.
abstract: BACKGROUND
  There are a limited number of approved treatments for papulopustular rosacea (PPR) and remission is difficult to maintain after successful treatment.
  
  
  OBJECTIVE
  To investigate remission over a 36-week extension period in patients with moderate to severe PPR successfully treated with 16 weeks' treatment with ivermectin 1% cream once daily (QD) or metronidazole 0.75% cream twice daily (BID) in a randomized, parallel-group Phase III study.
  
  
  METHODS
  Treatment was discontinued in patients initially successfully treated [Investigator's Global Assessment (IGA) score of 0 or 1] with ivermectin 1% cream QD (n = 399) or metronidazole 0.75% cream BID (n = 365; Part A) and patients were followed every 4 weeks for up to 36 weeks (Part B). Treatment with the same study treatment as used in Part A was only re-initiated if patients relapsed (IGA ≥ 2). Efficacy assessments were: time to first relapse; relapse rate; and number of days free of treatment. Safety assessments included incidence of adverse events and local cutaneous signs and symptoms.
  
  
  RESULTS
  The median time to first relapse was significantly longer (115 days vs. 85 days) and relapse rates at the end of the study period significantly lower (62.7% vs. 68.4%) for patients initially successfully treated with ivermectin 1% compared with metronidazole 0.75%; Kaplan-Meier plot demonstrated a statistically significant difference between the two arms (P = 0.0365). The median number of days free of treatment was higher for ivermectin compared with metronidazole (196 days vs. 169.5 days; P = 0.026). The percentage of patients who experienced a related adverse event was equally low in both groups.
  
  
  CONCLUSIONS
  The results of this relapse study showed that an initial successful treatment with ivermectin 1% cream QD significantly extended remission of rosacea compared with initial treatment with metronidazole 0.75% cream BID following treatment cessation.
authors.affiliation: Service de Dermatologie et Dermatologie Pédiatrique, Hôpital Saint-André, Bordeaux Cedex, France.
authors.forename: A
authors.initials: A
authors.lastname: Taieb
authors.affiliation: Dermatology Department, Centre Hospitalier Universitaire de Nice, Nice, France.
authors.forename: A
authors.initials: A
authors.lastname: Khemis
authors.affiliation: Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Ruzicka
authors.affiliation: Department of Dermatology, Venereology and Allergology, Medical University of Gdansk Poland, Gdansk, Poland.
authors.forename: W
authors.initials: W
authors.lastname: Barańska-Rybak
authors.affiliation: Dermatology Clinical Research Unit, Department of Dermatology, George Eliot Hospital, Nuneaton, UK.
authors.forename: J
authors.initials: J
authors.lastname: Berth-Jones
authors.affiliation: Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Schauber
authors.affiliation: Galderma R&D, Sophia Antipolis, France.
authors.forename: P
authors.initials: P
authors.lastname: Briantais
authors.affiliation: Galderma R&D, Sophia Antipolis, France.
authors.forename: J
authors.initials: J
authors.lastname: Jacovella
authors.affiliation: Dermatology Department, Centre Hospitalier Universitaire de Nice, Nice, France.
authors.forename: T
authors.initials: T
authors.lastname: Passeron
mesh_terms: D006801:Humans; D007559:Ivermectin / Q000008:administration & dosage*; D008795:Metronidazole / Q000008:administration & dosage*; D012074:Remission Induction; D012393:Rosacea / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D008795:Metronidazole; D007559:Ivermectin