Investigator-masked comparison of tazarotene gel q.d. plus mometasone furoate cream q.d. vs. mometasone furoate cream b.i.d. in the treatment of plaque psoriasis

Seventy-three patients with stable plaque psoriasis entered an investigator-masked trial comparing once-daily tazarotene 0.1% gel plus once-daily mometasone furoate 0.1% cream with twice-daily mometasone furoate 0.1% cream. The aim of the study was to determine whether tazarotene and mometasone furoate act synergistically-a previous study showed that tazarotene plus mometasone furoate offered greater efficacy than tazarotene alone, and this study investigated whether tazarotene plus mometasone furoate also offered greater efficacy than mometasone furoate alone. The patients had psoriasis affecting up to 20% of their total body surface area, with at least moderate plaque elevation. Washout periods were: 2 weeks for UVB phototherapy or topical antipsoriatic therapies; 4 weeks for psoralen plus UVA (PUVA) therapy or systemic antipsoriatic drugs other than retinoids; and 8 weeks for oral retinoids. All patients gave written informed consent and the study was conducted in compliance with the ethical standards of the governing institutional review boards and the Declaration of Helsinki. Patients were treated for up to 12 weeks. If they achieved clearance by week 4, or at least 50% global improvement by week 12, they were entered into the 12-week no-treatment follow-up phase. Patients were evaluated every 4 weeks in terms of percentage global improvement, plaque elevation, scaling, erythema, and pruritus. They also rated the efficacy of their own treatment (as very effective, effective, neutral, ineffective, or less effective) and the duration of improvement in their psoriasis (as much better, better, somewhat better, indifferent, or worse than that achieved with other topical medications they had used in the past). The two regimens were compared by analysis of variance, with the last recorded score for any patient who discontinued prematurely (due to lack of efficacy, adverse events, or disease flare) being carried forward to all subsequent visits.