Efficacy of Tropical Sertaconazole Nitrate 2% Vs Clotrimazole 1% for Tinea Pedis

Jinnah Postgraduate Medical Centre

Status and phase: Not yet enrolling; Phase 4

Conditions: Tinea Pedis

Treatments: Drug: Topical Sertaconazole 2%; Drug: Clotrimazole 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT06869681

No.F.2-81/2024-GENL/88/JPMC (Other Identifier)

Details and patient eligibility

About

This randomized controlled trail study will be carried out on OPD patients in the Department of Dermatology, Jinnah Postgraduate Medical Center. Institutional Ethical committee permission will be obtained and clinical trial registration number (CTN) will be obtained for the study. Written consent will obtained from all the participants of the study.

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.

Full description

This randomized controlled trail study will be carried out on OPD patients in the Department of Dermatology, Jinnah Postgraduate Medical Center. Institutional Ethical committee permission will be obtained and clinical trial registration number (CTN) will be obtained for the study. Written consent will obtained from all the participants of the study.

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of age 18-65 years age.
• 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 with secondary bacterial infection.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group-A topical Sertaconazole 2%

Experimental group

Description:

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.

Treatment:

Drug: Topical Sertaconazole 2%

Group-B Clotrimazole 1%

Experimental group

Description:

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.

Treatment:

Drug: Clotrimazole 1%