Abstract | BACKGROUND: OBJECTIVES: 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:
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Authors | Bárður Sigurgeirsson, Koen van Rossem, Steven Malahias, Kerry Raterink |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 69
Issue 3
Pg. 416-25
(Sep 2013)
ISSN: 1097-6787 [Electronic] United States |
PMID | 23706639
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved. |
Chemical References |
- Antifungal Agents
- Quinazolines
- Triazoles
- albaconazole
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Topics |
- Administration, Oral
- Adult
- Aged
- Antifungal Agents
(administration & dosage, adverse effects, pharmacokinetics)
- Double-Blind Method
- Female
- Foot Dermatoses
(drug therapy)
- Humans
- Male
- Middle Aged
- Onychomycosis
(drug therapy)
- Quinazolines
(administration & dosage, adverse effects, pharmacokinetics)
- Time Factors
- Treatment Outcome
- Triazoles
(administration & dosage, adverse effects, pharmacokinetics)
- Young Adult
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