UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045232 |
|---|---|
| Receipt number | R000051000 |
| Scientific Title | The elucidation of influence and mechanisms of antifungal drugs to skin disorders caused by molecular target drugs |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2023/11/26 11:44:49 |
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Basic information
Public title
The elucidation of influence and mechanisms of antifungal drugs to skin disorders caused by molecular target drugs
Acronym
The elucidation of influence and mechanisms of antifungal drugs to skin disorders caused by molecular target drugs
Scientific Title
The elucidation of influence and mechanisms of antifungal drugs to skin disorders caused by molecular target drugs
Scientific Title:Acronym
The elucidation of influence and mechanisms of antifungal drugs to skin disorders caused by molecular target drugs
Region
| Japan |
Condition
Condition
Hand foot syndrome
Keratosis
Classification by specialty
| Hematology and clinical oncology | Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate influence of antifungal drugs to skin disorders caused by molecular target drugs.
Patient with keratosis on hand or/and foot is also the subject of research.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the skin condition of Hand foot syndrome caused by molecular target drugs and observe the changes of the skin with topical antifungal drugs every month.
Patient with keratosis on hand or/and foot is also the subject of research.
Key secondary outcomes
Area of damaged skin
Degree of pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with hand foot syndrome or keratosis apply Ketoconazole cream twice a day to hand or/and foot which lesioned part exist for 1 year.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hand foot syndrome patient caused by molecular target drug
Patient with keratosis on hand or/and foot
Key exclusion criteria
Patient who is ruled unfit to our research by us
Patient without consent to the research participation
Pregnant woman
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Takamori |
Organization
Juntendo university
Division name
Institute for Environmental and Genter-Specific Medicine
Zip code
279-0021
Address
2-1-1 Tomioka,Urayasu,Chiba
TEL
0473533171
kankyoken@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Takamori |
Organization
Juntendo university
Division name
Institute for Environmental and Genter-Specific Medicine
Zip code
279-0021
Address
2-1-1 Tomioka,Urayasu,Chiba
TEL
0473533171
Homepage URL
r-kato@juntendo.ac.jp
Sponsor or person
Institute
Institute for Environmental and Genter-Specific Medicine
Institute
Department
Personal name
Funding Source
Organization
Kaken PharmaceuticalCo.,LTD.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Rearch and Trial Center
Address
3-1-3
Tel
0338145672
urayasu.rinri.sibu@juntendo.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling by invitation
Management information
Registered date
| 2021 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051000
