Efficacy of Tropical Sertaconazole Nitrate 2% Vs Clotrimazole 1% for Tinea Pedis
NCT ID: NCT06869681
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-03-01
2025-06-15
Brief Summary
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All the diagnosed patients of Tinea Pedis who will meet the selection criteria will be enrolled and will be educated regarding the study. Participants will be randomly allocated in into two groups utilizing envelop method; patients of Group-A will use topical Sertaconazole 2% and patients in Group-B will use Clotrimazole 1%.
Randomization: Random number sequence will be generated on computer by a simple randomization schedule. Each randomization number will be sealed in an opaque envelope with a serial number on it. The patient with a known serial number opened the corresponding envelope to be informed of the assignment.
Treatment: After cleaning the identified lesions, the patients will topically self-apply the both products/creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. Both the creams will be applied topically twice daily for 4 weeks.
Patients will be followed up weekly for clinical improvement and side-effects of therapy upto 4 weeks of the treatment. At final follow up (after 4 week of treatment), the patients will be evaluated by all clinical investigations and microscopic examination (10% potassium hydroxide) of a skin scraping from site of the lesion. Adverse effects of the drugs among all patients will also be recorded. The photograph of the lesions taken before treatment and at the end of the study will be used for assessing the clinical improvement of the cases.
Detailed questionnaires will be followed regarding demographic and clinical characteristics like age, BMI, symptoms and co morbidities etc. Proper selection criteria will be used to control any biasness. Efficacy will be reported as per operational definition. In case of, topical therapy will be terminated and the concerned patient will be switched over to an oral antifungal drug at the discretion of the dermatologist. Any adverse events during the study will also be reported.
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Detailed Description
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All the diagnosed patients of Tinea Pedis who will meet the selection criteria will be enrolled and will be educated regarding the study. Participants will be randomly allocated in into two groups utilizing envelop method; patients of Group-A will use topical Sertaconazole 2% and patients in Group-B will use Clotrimazole 1%.
Randomization: Random number sequence will be generated on computer by a simple randomization schedule. Each randomization number will be sealed in an opaque envelope with a serial number on it. The patient with a known serial number opened the corresponding envelope to be informed of the assignment.
Treatment: After cleaning the identified lesions, the patients will topically self-apply the both products/creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. Both the creams will be applied topically twice daily for 4 weeks.
Patients will be followed up weekly for clinical improvement and side-effects of therapy upto 4 weeks of the treatment. At final follow up (after 4 week of treatment), the patients will be evaluated by all clinical investigations and microscopic examination (10% potassium hydroxide) of a skin scraping from site of the lesion. Adverse effects of the drugs among all patients will also be recorded. The photograph of the lesions taken before treatment and at the end of the study will be used for assessing the clinical improvement of the cases.
Detailed questionnaires will be followed regarding demographic and clinical characteristics like age, BMI, symptoms and co morbidities etc. Proper selection criteria will be used to control any biasness. Efficacy will be reported as per operational definition. In case of, topical therapy will be terminated and the concerned patient will be switched over to an oral antifungal drug at the discretion of the dermatologist. Any adverse events during the study will also be reported.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group-A topical Sertaconazole 2%
After cleaning the identified lesions, the patients will topically self-apply the topical Sertaconazole 2% creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. The creams will be applied topically twice daily for 4 weeks.
Patients will be followed up weekly for clinical improvement and side-effects of therapy upto 4 weeks of the treatment.
Topical Sertaconazole 2%
After cleaning the identified lesions, the patients will topically self-apply the both products/creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. Both the creams will be applied topically twice daily for 4 weeks.
Group-B Clotrimazole 1%
After cleaning the identified lesions, the patients will topically self-apply the Clotrimazole 1% creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. Both the creams will be applied topically twice daily for 4 weeks.
Clotrimazole 1%
Same as above
Interventions
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Topical Sertaconazole 2%
After cleaning the identified lesions, the patients will topically self-apply the both products/creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. Both the creams will be applied topically twice daily for 4 weeks.
Clotrimazole 1%
Same as above
Eligibility Criteria
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Inclusion Criteria
* Either sex.
* Patients presenting with the clinical manifestations of tinea pedis such as erythema, scaling, vesicles, pustules, and itch.
* Skin scrapings positive for KOH mount test.
Exclusion Criteria
* Patients using topical or taken any oral antifungal drug before the baseline visit.
* Diabetic, immunocompromised patients.
* Women with pregnancy or lactating mothers.
* Patients allergic to the drugs in this study.
* Those who withdrew in the middle of the study, or changed drugs without authorization will also be excluded.
18 Years
65 Years
ALL
No
Sponsors
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Jinnah Postgraduate Medical Centre
OTHER_GOV
Responsible Party
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Dr. Madhoo, MBBS
Doctor, FCPS Trainee
Central Contacts
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Other Identifiers
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No.F.2-81/2024-GENL/88/JPMC
Identifier Type: OTHER
Identifier Source: secondary_id
No.F.2-81/2024-GENL/88/JPMC
Identifier Type: -
Identifier Source: org_study_id
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