Pereda 2003.
Methods | RCT Study aim clearly defined: yes Blinded assessor of primary outcome: no Double blind study: yes Participants comparable at baseline for age: yes Sex: yes Duration of complaint: yes Inclusion and exclusion criteria specified: yes Interventions well described: yes Assessment of compliance: no Intention to treat analysis: no A Priori sample size calculation: not stated Fungi identified: yes Distribution of species between groups: yes Adverse events reported: yes Number of drop outs stated: ten | |
Participants | Total evaluable sample size:264 Treatment setting: 11 Dermatology outpatient clinics in Spain Inclusion criteria: + ve KOH and culture systemic antimycotic within four weeks of trial entry, topical antifungals within seven days. Concurrent therapy with steroids or other antifungal agent. |
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Interventions | a. Bifonazole 1% powder b. Flutrimazole 1% powder Both applied 2 X daily for 4 weeks. |
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Outcomes | Primary outcome:Clinical cure = total signs and symptoms score of < 2. Global cure clinical cure plus negative microscopy |
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Notes | Adverse events;non serious. Dishydrotic eczema by one in bifonazole group. Itching by one in bifonazole group and one in fluconazole group. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |