A phase II, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of oral albaconazole in patients with distal subungual onychomycosis - 17/08/13
, Koen van Rossem, MD, PhD b, Steven Malahias, BS b, Kerry Raterink, MS bAbstract |
Background |
Onychomycosis is effectively treated with terbinafine and itraconazole. However, frequent repeated dosing is required, and hepatic and cardiac adverse events may occur.
Objectives |
Evaluate efficacy and safety of albaconazole, a novel triazole, for once-weekly treatment of distal subungual onychomycosis of the great toenail.
Methods |
This double-blind, phase II study randomized 584 patients to receive albaconazole 100 to 400 mg or placebo weekly for 24 or 36 weeks. Effective treatment was measured as mycologic cure and clear or almost clear nail at week 52.
Results |
All treatment groups achieved greater effective treatment rates (21%-54%) compared to placebo (1%; P < .001 for all groups) at week 52. Effective treatment was attained at week 24 in ≥5% of patients in most groups. Most adverse events were mild or moderate, and treatment-related adverse events were all ≤3%. No treatment-related hepatic or cardiac serious adverse events were observed.
Limitations |
The follow-up period was likely too short to detect maximal efficacy; cure rates were increasing at study end. The efficacy and tolerability of albaconazole were not compared with other available treatments, and the global change in target toenail scale was subjective.
Conclusions |
Albaconazole was well tolerated at all doses and resulted in high cure rates for onychomycosis.
Le texte complet de cet article est disponible en PDF.Key words : albaconazole, dermatophyte, nail fungus, onychomycosis, phase II study, triazole
Abbreviations used : AE, ECG, ITT, KOH, PK, PP, SAE, SD, TEAE
Plan
| Supported by Stiefel, a GSK company. |
|
| Dr Sigurgeirsson was a sponsored investigator on this study and a member of an advisory board that assisted in the planning and design of the study. He also has served as a consultant and investigator for and received honoraria from Arpedia, Celtic, deCode, Galderma, Novartis, Prostrakan, Stiefel, TLT, Topica, and Vertex. Dr van Rossem, Mr Malahias, and Ms Raterink are employees of Stiefel, a GSK company. The registration number for this trial is NCT00730405. |
Vol 69 - N° 3
P. 416 - septembre 2013 Retour au numéro
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