Oral liarozole in the treatment of patients with moderate/severe lamellar ichthyosis: results of a randomized, double-blind, multinational, placebo-controlled phase II/III trial.
Bottom Line: Mean IGA and scaling scores decreased from baseline in both liarozole groups at weeks 8 and 12 vs. placebo; erythema and pruritus scores were similar between treatment groups.Treatment with liarozole for 12 weeks was well tolerated.The primary efficacy variable did not reach statistical significance, possibly owing to the small sample size following premature termination.
Affiliation: Department of Medical Sciences, Uppsala University, SE-751 85, Uppsala, Sweden.Show MeSH
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Mentions: As no significant difference was demonstrated for the primary efficacy variable, formalstatistical analyses were not planned to be performed on secondary efficacy variables, as per thestudy statistical analysis plan. Statistical analyses were, however, performed posthoc and are provided for information in Table S1 (see Supporting Information). Comparedwith the placebo group, mean IGA score decreased from baseline to weeks 8 and 12 in the 75- and150-mg liarozole groups and returned to near baseline values at the follow-up visit (Fig.3). Mean scaling score, but not erythema or pruritus scores, alsodecreased from baseline to weeks 8 and 12 in the 75- and 150-mg liarozole groups compared with theplacebo group (Fig.4). No obvious difference in the use ofmechanical scale removal and emollients was observed between treatment groups. The use of emollientsremained stable during the treatment period in the placebo and the 150-mg liarozole groups; a slightdecrease was observed in the 75-mg liarozole group.
Affiliation: Department of Medical Sciences, Uppsala University, SE-751 85, Uppsala, Sweden.