Abstract | OBJECTIVE: PATIENTS/METHODS: A total of 131 patients were randomized to treatment. Patients in the combination groups were treated with amorolfine 5% nail lacquer ( Loceryl, Galderma Laboratories) once weekly for 24 weeks and 200 mg itraconazole once daily for 6 weeks (Group AI-6) or 12 weeks (Group AI-12). A control group received itraconazole monotherapy for 12 weeks (Group 1-12). Strict inclusion criteria specified that subjects had to have onychomycosis of the toenails with matrix area involvement and/or > 80% total nail surface involvement. Mycological evaluations using both microscopic examination and culture of nail samples were performed at weeks 12 and 24. A stringent assessment of outcome at study end combined the results of mycological and clinical outcomes into a global cure rate. Safety was also assessed. RESULTS: At week 12, mycological cure was attained in 42 of 45 patients (93.3%) in group AI-6, 29 of 35 patients (82.9%) in group AI-12, and 14 of 34 patients in group 1-12. The difference between both combination groups and the control group were significant (P < 0.001). The global cure rate at week 24 was 83.7% (36 patients) in group AI-6, 93.9% (31 patients) in group AI-12, and 68.8% (22 patients) in group I-12. The difference between the AI-12 group and itraconazole monotherapy was significant (P < 0.05). CONCLUSIONS:
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Authors | M Lecha |
Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 145 Suppl 60
Pg. 21-6
(Oct 2001)
ISSN: 0007-0963 [Print] England |
PMID | 11777261
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antifungal Agents
- Morpholines
- Itraconazole
- amorolfine
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Topics |
- Administration, Oral
- Administration, Topical
- Antifungal Agents
(administration & dosage, economics, therapeutic use)
- Drug Costs
- Drug Therapy, Combination
- Female
- Foot Dermatoses
(drug therapy)
- Humans
- Itraconazole
(administration & dosage, economics, therapeutic use)
- Male
- Middle Aged
- Morpholines
(administration & dosage, economics, therapeutic use)
- Onychomycosis
(drug therapy)
- Treatment Outcome
- Trichophyton
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