Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability

Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268.

Abstract

This study was a prospective, parallel-group, randomized, double-blind, vehicle-controlled, multi-centre clinical trial to compare the efficacy of topical sertaconazole 2% cream with vehicle in reducing chronic pruritus in subjects with atopic dermatitis, and to assess its safety and local tolerability. A total of 70 subjects applied either of the 2 treatments twice daily for a period of 4 weeks on affected, itchy skin areas. Treatment efficacy was evaluated primarily considering the item itch intensity on a 5-point verbal rating scale. Insomnia, state of atopic dermatitis (Scoring Atopic Dermatitis; SCORAD), quality of life and therapy benefit were also assessed. No significant difference between active treatment and vehicle was found at any of the time-points for any of the investigated parameters. Under the experimental conditions of the study, sertaconazole 2% cream did not exert anti-pruritic effects that were better than vehicle in subjects with atopic dermatitis who had chronic pruritus. Trial registration ClinicalTrials.gov #NCT01792713.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antifungal Agents / therapeutic use*
  • Dermatitis, Atopic / drug therapy*
  • Double-Blind Method
  • Female
  • Germany
  • Humans
  • Imidazoles / therapeutic use*
  • Male
  • Middle Aged
  • Prospective Studies
  • Pruritus / drug therapy*
  • Thiophenes / therapeutic use*
  • Treatment Outcome

Substances

  • Antifungal Agents
  • Imidazoles
  • Thiophenes
  • sertaconazole

Associated data

  • ClinicalTrials.gov/NCT01792713