title: Mometasone furoate 0.1%-salicylic acid 5% ointment twice daily versus fluocinonide 0.05% ointment twice daily in the management of patients with psoriasis.
abstract: This study compared the clinical efficacy and safety of the combination agent mometasone furoate 0.1%-salicylic acid 5% ointment with those of the single agent fluocinonide 0.05% ointment, each applied twice daily for 21 days, in the treatment of patients with moderate to severe plaque psoriasis. Forty adult patients were included in this single-center, randomized, double-masked, intraindividual, bilateral-paired comparative trial. Two similar, bilaterally symmetrical target lesions on the trunk, arms, or legs of each patient were selected for treatment and evaluation. One lesion was treated with mometasone furoate 0.1%-salicylic acid 5% ointment, and the other was treated with fluocinonide 0.05% ointment, both twice daily for 21 days. Treatment was randomly assigned to the right or left side of the body. Signs of psoriasis (ie, erythema, induration, and scaling) and overall clinical response were evaluated and scored on days 4, 8, 15, and 22 and compared against baseline. Patients were asked to evaluate the treatments for efficacy and acceptability at each visit. The primary efficacy parameter was the mean percentage of improvement in total sign scores for the target lesions. Safety was evaluated based on clinical observation and patients' reports. Beginning with day 15, statistically significant differences favoring mometasone furoate 0.1%-salicylic acid 5% ointment over fluocinonide 0.05% ointment were seen in individual and total sign scores, as well as in overall global clinical response. On day 15, 20 patients expressed a preference for one treatment over the other, and 20 patients made no distinction between the two. Of those who expressed a preference, significantly more patients believed mometasone furoate 0.1%-salicylic acid 5% ointment to be better than fluocinonide 0.05% ointment. On day 22, of 25 patients who expressed a preference, significantly more patients thought mometasone furoate 0.1%-salicylic acid 5% ointment was better than fluocinonide 0.05% ointment. No adverse events were recorded for either treatment group. The combination mometasone furoate 0.1%-salicylic acid 5% ointment was significantly more efficacious than and equally as safe as fluocinonide 0.05% ointment in the management of patients with plaque psoriasis and was preferred by a greater number of patients.
authors.affiliation: Schering-Plough Research Institute, Kenilworth, New Jersey, USA.
authors.forename: R S
authors.initials: RS
authors.lastname: Medansky
authors.forename: C A
authors.initials: CA
authors.lastname: Cuffie
authors.forename: D J
authors.initials: DJ
authors.lastname: Tanner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005447:Fluocinonide / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D017060:Patient Satisfaction; D011244:Pregnadienediols / Q000627:therapeutic use*; D011565:Psoriasis / Q000188:drug therapy*; D012459:Salicylates / Q000627:therapeutic use*; D020156:Salicylic Acid; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D012459:Salicylates; D000068656:Mometasone Furoate; D005447:Fluocinonide; D020156:Salicylic Acid