Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062180) titled 'Toe Separators for Interdigital Tinea Pedis Treatment' on July 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Fazaia PostGraduate Medical Institute
Department of Dermatology, PAF Hospital Islamabad.
Condition:
Condition - Interdigital Tinea Pedis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of adjunctive use of toe separators in combination with topical clotrimazole compared with topical clotrimazole alone in the treatment of interdigital tinea pedis.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - * Type: Intervention
* Name: Toe separators plus topical clotrimazole
* Description: Participants will receive topical clotrimazole together with toe separators for 6 weeks.
Interventions/Control_2 - * Type: Control
* Name: Topical clotrimazole alone
* Description: Participants will receive topical clotrimazole alone for 6 weeks.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - * Adults aged 18 to 70 years.
* Clinical diagnosis of interdigital tinea pedis (maceration, fissuring, exudation with itching, burning, or malodour, typically involving the 3rd-4th or 4th-5th interdigital spaces).
* Ability and willingness to provide written informed consent.
Key exclusion criteria - * Presence of other inflammatory foot conditions (e.g., pompholyx).
* Presence of non-interdigital forms of tinea pedis (vesiculobullous, moccasin, or ulcerative types).
* Current use of oral antifungal medication
Target Size - 102
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 11 Month 01 Day
Date of IRB - 2025 Year 11 Month 01 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071154
Disclaimer: Curated by HT Syndication.