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Fungal nail infection (onychomycosis) - Evidence
Evidence on oral itraconazole compared with oral itraconazole plus a topical antifungal
There is weak evidence from one randomized controlled trial (RCT) that adding amorolfine to oral itraconazole improves the cure rate of dermatophyte onychomycosis. No RCTs have assessed the benefit of adding topical tioconazole.
CKS found two RCTs which compared oral itraconazole with oral itraconazole plus topical antifungals for dermatophyte onychomycosis.
Oral itraconazole compared with oral itraconazole plus topical amorolfine
- An RCT (n = 131) found that topical amorolfine added to oral itraconazole increased global cure rates of people with onychomycosis of the toenails [Lecha, 2001].
- Participants were randomized to receive one of three treatment regimens:
- Amorolfine 5% nail lacquer applied once weekly for 24 weeks and itraconazole 200 mg once daily for 6 weeks (group AI-6), or
- Amorolfine 5% nail lacquer applied once weekly for 24 weeks and itraconazole 200 mg once daily for 12 weeks (group AI-12), or
- Itraconazole 200 mg for 12 weeks (group I-12).
- At week 24 the global cure rates for groups AI-6, AI-12, and I-12 were: 84%, 94%, and 69% (p < 0.05 for the difference between the AI-12 and I-12 groups).
- An RCT (n = 90) found that amorolfine 5% solution nail lacquer added to itraconazole pulse therapy did not increase the cure rate of Candida fingernail onychomycosis [Rigopoulos et al, 2003].
- Participants were randomized to receive one of two treatments:
- Itraconazole pulse therapy for 2 months, and amorolfine 5% solution nail lacquer applied once a week for 6 months, or
- Itraconazole pulse therapy for 3 months.
- The primary efficacy criterion was the result of mycological examination at 3 months.
- The secondary criterion was the combined mycological and clinical response at 9 months.
- A pharmacoeconomic analysis was also performed to compare the cost-effectiveness of combined therapy with monotherapy.
- Results were analysed for 85 participants.
- Paronychial involvement was evident in 71 people.
- Candida albicans was isolated in 85 people, Candida parapsilosis in three people, and other Candida species in two people.
- At 9 months, the global cure rates in the combined therapy and monotherapy groups were 93% and 81% (p > 0.1).
Oral itraconazole compared with oral itraconazole plus topical tioconazole
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