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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
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Dermatology and Venereology.
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2014 (English)In: British Journal of Dermatology, ISSN 0007-0963, E-ISSN 1365-2133, Vol. 170, no 1, 173-181 p.Article in journal (Refereed) Published
Abstract [en]

Background

Oral liarozole, a retinoic acid metabolism-blocking agent, may be an alternative to systemic retinoid therapy in patients with lamellar ichthyosis.

Objective

To demonstrate the efficacy and safety of once-daily oral liarozole in the treatment of moderate/severe lamellar ichthyosis.

Methods

This was a double-blind, multinational, parallel phase II/III trial (NCT00282724). Patients aged >= 14 years with moderate/severe lamellar ichthyosis [ Investigator's Global Assessment (IGA) score >= 3] were randomized 3 : 3 : 1 to receive oral liarozole (75 or 150 mg) or placebo once daily for 12 weeks. Assessments included: IGA; a five-point scale for erythema, scaling and pruritus severity; Short Form-36 health survey; Dermatology Life Quality Index (DLQI); and safety parameters. The primary efficacy variable was response rate at week 12 (responder: >= 2-point decrease in IGA from baseline).

Results

Sixty-four patients were enrolled. At week 12, 11/27 (41%; liarozole 75 mg), 14/28 (50%; liarozole 150 mg) and one out of nine (11%; placebo) patients were responders; the difference between groups (liarozole 150 mg vs. placebo) was not significant (P = 0.056). 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. Improvement in DLQI score was observed in both liarozole groups. Treatment with liarozole for 12 weeks was well tolerated.

Conclusions

The primary efficacy variable did not reach statistical significance, possibly owing to the small sample size following premature termination. However, once-daily oral liarozole, 75 and 150 mg, improved scaling and DLQI and was well tolerated in patients with moderate/severe lamellar ichthyosis.

Place, publisher, year, edition, pages
2014. Vol. 170, no 1, 173-181 p.
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-218453DOI: 10.1111/bjd.12627ISI: 000329530200066OAI: oai:DiVA.org:uu-218453DiVA: diva2:695702
Available from: 2014-02-12 Created: 2014-02-12 Last updated: 2017-12-06Bibliographically approved

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