Fungal nail disease (Onychomycosis). Candidiasis of skin and nail: Candidal onychia
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: ciclopirox nail lacquer treatment: Patients receive ciclopirox nail lacquer for topical treatment daily (twice) for 4 to 8 weeks along with oral
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male or female 18 years or older Diagnosis of onychomycosis using examination and examination by a dermatologist (clinical diagnosis) Confirmation of the diagnosis by routine mycological methods Patient availability during the study period (6-8 weeks) Willingness to comply with the study protocol No use of systemic antifungal drugs in the last month No use of topical antifungal drugs or antifungal shampoos in the 2 weeks before treatment No allergy to ciclopirox Informed consent
Exclusion criteria
Exclusion criteria: Having a bacterial nail infection History of taking antifungal medications in the previous month Allergy to medication Failure to cooperate with the doctor Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective treatment of fungal infection: This treatment includes the elimination of the fungus and a negative result of mycological tests. Timepoint: 4 to 8 weeks after starting treatment. Method of measurement: Microscopic examination and culture of the nail sample.;Reduction of clinical symptoms. Timepoint: 4 to 8 weeks after starting treatment. Method of measurement: Physician scoring (0-3) of six clinical signs of onychomycosis, including nail discoloration, brittleness, thickness change, onycholysis, and paraonychia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects: Unwanted effects from using antifungal solutions such as redness, burning, and swelling. Timepoint: 8 weeks after starting treatment. Method of measurement: Questionnaire.;Patient satisfaction score: The score that the patient gives to the effectiveness and outcome of their treatment. Timepoint: 8 weeksafter starting treatment. Method of measurement: At the end of treatment, patients will complete a short questionnaire-based survey about their perception of the tolerability, effectiveness, and comfort of the treatment on a five-point scale, where 0 = successful treatment and complete clearance of the fungus, 1 = excellent, 2 = good, 3 = poor, 4 = no change, 5 = worsening of the disease, or they may respond with “no answer/prefer not to say”.;Patient self-reported compliance: Patients are asked to estimate the number of doses of treatment they have missed to determine the extent to which they adhere to a treatment regimen. Timepoint: 4 weeks to eight weeks after starting treatment. Method of measurement: The questionnaire asks patients to estimate how many doses of treatment they have missed. Possible answers are 1-2, 3-4, 5-6, 7-8, or 9 or more. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKamiar Zomorodian
Shiraz University of Medical Sciences
Outcome results
None listed