Evaluation of skin irritation and contact sensitizing potential of fenticonazole.
A double blind, randomized clinical trial was performed on twelve healthy volunteers to evaluate the irritation potential of fenticonazole 2% cream (Lomexin) and spray versus micomazole 2% cream and econazole 1% spray. The contact-sensitizing potential of the two fenticonazole preparations was also investigated. There was no evidence of irritation after the treatments with fenticonazole cream, its excipients, miconazole cream and fenticonazole spray excipients, whereas signs of irritation were observed in four cases after treatment with the spray formulations (two after fenticonazole, two after econazole). The contact-sensitizing test was performed only with fenticonazole 2% cream and spray. Neither spray nor cream formulation of fenticonazole showed evidence of sensitization in any of the twelve subjects.
Pigatto
P
P
2nd Department of Dermatology, University of Milan, Italy.
Colli
E
E
Scatigna
M
M
Finzi
A
A
D000328:Adult; D003877:Dermatitis, Contact / Q000209:etiology*; D004341:Drug Evaluation; D004464:Econazole / Q000009:adverse effects; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects*; D007509:Irritants; D008297:Male; D008825:Miconazole / Q000009:adverse effects; D012882:Skin Tests
D007093:Imidazoles; D007509:Irritants; D004464:Econazole; D008825:Miconazole; C033486:fenticonazole