title: 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.
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.
authors.affiliation: Department of Dermatology, Competence Center Chronic Pruritus, University Hospital of Münster, Von-Esmarch-Str. 58, DE-48149 Münster, Germany sonja.staender@ukmuenster.de.
authors.forename: Sonja
authors.initials: S
authors.lastname: Ständer
authors.forename: Martin
authors.initials: M
authors.lastname: Metz
authors.forename: Mac H
authors.initials: MH
authors.lastname: Ramos F
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
authors.forename: Nicole
authors.initials: N
authors.lastname: Schoepke
authors.forename: Athanasios
authors.initials: A
authors.lastname: Tsianakas
authors.forename: Claudia
authors.initials: C
authors.lastname: Zeidler
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Luger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011537:Pruritus / Q000188:drug therapy*; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D007093:Imidazoles; D013876:Thiophenes; C061131:sertaconazole