A Phase 4 interventional study of Topical Sertaconazole 2% and Clotrimazole 1% in Tinea Pedis, sponsored by Jinnah Postgraduate Medical Centre. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Jinnah Postgraduate Medical Centre · Phase 4, Interventional, and Treatment
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.
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.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's planned enrollment of 100 is below the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Jinnah Postgraduate Medical Centre is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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%
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.
Same as above
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
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for May 2025, 2 months later.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sertaconazole · Clotrimazole
Jinnah Postgraduate Medical Centre