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

Comparison of Efficacy of Sertaconazole Nitrate Cream 2 Percent Vs Clotrimazole 1 Percent for the Treatment of Tinea Pedis.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Topical Sertaconazole 2%; Drug: Clotrimazole 1%

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr.Madhu FCPS Trainee, MBBS; Phone Number: +92-333-7545165; Email: madhujaish@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: Clotrimazole 1%; Same as above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of Efficacy in both treatment groups	Reduction in total composite score of at least 2 points with negative KOH test after 4 week of treatment and reporting of no adverse events will be considered as efficacy of the treatments	4 weeks

Collaborators and Investigators

• Sponsor: Jinnah Postgraduate Medical Centre

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Efficacy; Tinea Pedis; Clotrimazole; Sertaconazole Nitrate Cream
• Additional Relevant MeSH Terms: Infections; Skin Manifestations; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Foot Diseases; Mycoses; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea Pedis; Tinea; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Anti-Infective Agents, Local; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; 14-alpha Demethylase Inhibitors; Clotrimazole; Miconazole; Sertaconazole
• Other Study ID Numbers: No.F.2-81/2024-GENL/88/JPMC (Other Identifier: Jinnah Postgraduate Medical Centre(JPMC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No