Limits...
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.

Vahlquist A, Blockhuys S, Steijlen P, van Rossem K, Didona B, Blanco D, Traupe H - Br. J. Dermatol. (2014)

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.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Sciences, Uppsala University, SE-751 85, Uppsala, Sweden.

Show MeSH

Related in: MedlinePlus

Mean symptom scores over time: (a) scaling, (b) erythema and (c) pruritus (intent-to-treatpopulation; last observation carried forward). For results of post hoc statisticalanalysis, see Table S1.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4232915&req=5

fig04: Mean symptom scores over time: (a) scaling, (b) erythema and (c) pruritus (intent-to-treatpopulation; last observation carried forward). For results of post hoc statisticalanalysis, see Table S1.

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.


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.

Vahlquist A, Blockhuys S, Steijlen P, van Rossem K, Didona B, Blanco D, Traupe H - Br. J. Dermatol. (2014)

Mean symptom scores over time: (a) scaling, (b) erythema and (c) pruritus (intent-to-treatpopulation; last observation carried forward). For results of post hoc statisticalanalysis, see Table S1.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4232915&req=5

fig04: Mean symptom scores over time: (a) scaling, (b) erythema and (c) pruritus (intent-to-treatpopulation; last observation carried forward). For results of post hoc statisticalanalysis, see Table S1.
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.

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.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Sciences, Uppsala University, SE-751 85, Uppsala, Sweden.

Show MeSH
Related in: MedlinePlus