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Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label reveal trial

Journal of the American Academy of Dermatology Feb 11, 2018

Draelos ZD, et al. - The intention of the authors was to gauge the long-term safety and efficacy of oxymetazoline cream 1.0% in rosacea patients with moderate to severe persistent erythema. Data disclosed that rebound effect was experienced by less than 1% of patients following treatment cessation. Sustained safety, tolerability, and efficacy was illustrated of oxymetazoline for moderate to severe persistent erythema of rosacea.

Methods

  • During this research, patients applied oxymetazoline once daily for 52 weeks.
  • Treatment-emergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect served as the safety assessments.
  • In order to gauge the efficacy, experts used the Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) composite score at 3 and 6 hours postdose on day 1 and weeks 4, 26, and 52.

Results

  • Out of 440 patients, 8.2% reported treatment-related TEAEs, with application-site dermatitis, paresthesia, pain, and pruritus being most common.
  • Findings revealed the discontinuation rate to be 3.2% due to adverse events (mostly application-site TEAEs).
  • With regard to skin blanching, inflammatory lesions, or telangiectasia, there were no clinically significant variations.
  • As per the outcomes, 36.7% and 43.4% of patients displayed ≥2-grade composite improvement from baseline in both CEA and SSA at 3 and 6 hours postdose, respectively at week 52.
  • After treatment cessation, less than 1% of patients presented with rebound effect.

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