UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062180 |
|---|---|
| Receipt number | R000071154 |
| Scientific Title | Evaluating Adjunctive Use of Toe Separators and Topical Clotrimazole in Interdigital Tinea Pedis Treatment: A Randomized Single Blind Controlled Trial |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/08 19:19:41 |
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Basic information
Public title
Toe Separators for Interdigital Tinea Pedis Treatment
Acronym
TOE-TIP
Scientific Title
Evaluating Adjunctive Use of Toe Separators and Topical Clotrimazole in Interdigital Tinea Pedis Treatment: A Randomized Single Blind Controlled Trial
Scientific Title:Acronym
Evaluating Adjunctive Use of Toe Separators and Topical Clotrimazole in Interdigital Tinea Pedis Treatment: A Randomized Single Blind Controlled Trial (TOE-TIP)
Region
| Asia(except Japan) |
Condition
Condition
Interdigital Tinea Pedis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment response at 6 weeks, classified as complete cure, partial cure, or treatment failure based on clinical assessment of signs and symptoms of interdigital tinea pedis.
Key secondary outcomes
* Resolution of itching
* Resolution of burning sensation
* Resolution of maceration
* Resolution of fissures
* Resolution of exudation
* Treatment adherence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | 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 sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Qurat |
| Middle name | Ul ain |
| Last name | Bangish |
Organization
PAF HOSPITAL, FAZAIA POST GRADUATE MEDICAL INSTITUTE ISLAMABAD
Division name
DEPARTMENT OF DERMATOLOGY
Zip code
44000
Address
Department of Dermatology, PAF Hospital Islamabad, E-9, Islamabad, Pakistan
TEL
+923190533393
quratulainbangish@gmail.com
Public contact
Name of contact person
| 1st name | Qurat |
| Middle name | Ul ain |
| Last name | Bangish |
Organization
PAF Hospital Islamabad, Fazaia Postgraduate Medical Institute
Division name
Department of Dermatology
Zip code
44000
Address
Department of Dermatology, PAF Hospital Islamabad, E-9, Islamabad, Pakistan
TEL
+923190533393
Homepage URL
quratulainbangish@gmail.com
Sponsor or person
Institute
Fazaia PostGraduate Medical Institute
Department of Dermatology, PAF Hospital Islamabad.
Institute
Department
Personal name
Funding Source
Organization
No funding
Self-funded / Investigator-initiated
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee, Fazaia Postgraduate Medical Institute (FPGMI), Islamabad
Address
Ethical Review Committee, Fazaia Postgraduate Medical Institute, PAF Hospital Islamabad, E-9, Islamabad 44000, Pakistan
Tel
+92519566004
FPGMI.ibd@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Department of Dermatology, PAF Hospital Islamabad (Islamabad)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071154
