UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029695 |
|---|---|
| Receipt number | R000033930 |
| Scientific Title | Phase I/II study on the safety and efficacy of repeated administration of FIT039 transdermal patch for verrucas caused by human papilloma-virus |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2020/12/11 18:05:46 |
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Basic information
Public title
Phase I/II study on the safety and efficacy of repeated administration of FIT039 transdermal patch for verrucas caused by human papilloma-virus
Acronym
Evaluation on the safety and efficacy of repeated administration of FIT039 for verrucas
Scientific Title
Phase I/II study on the safety and efficacy of repeated administration of FIT039 transdermal patch for verrucas caused by human papilloma-virus
Scientific Title:Acronym
Evaluation on the safety and efficacy of repeated administration of FIT039 for verrucas
Region
| Japan |
Condition
Condition
Phase I/II study on the safety and therapeutic efficacy of repeated administration of FIT039 transdermal patch on verrucas caused by human papillomavirus
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and therapeutic efficacy of application of 3% FIT039 or placebo transdermal patch once per day for 14 days
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) Safety: Adverse events and side effects
2) Efficacy: the disappearance of warts
Key secondary outcomes
1) Wart area
2) Number of petechial bleeding images
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Apply one study drug once a day for 14 days to the wart area after a cryotherapy
Interventions/Control_2
Apply one placebo once a day for 14 days to the wart area after a cryotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women who meet the following criteria:
1. Having verruca vulgaris, measuring 4 to 10 mm on the major axis, on the extremities, including the palms and soles.
2. Aged over 20 years old at the time of consent.
3. Blood test within 4 weeks prior to the registration fulfills all of the followings: hemoglobin level = or > 10 g/dL, white blood cell count = or > 2,000/microL, platelet count = or > 100,000/microL, AST/GOT = or < 100 IU/L, ALT/GPT = or > 100 IU/L, total bilirubin = or < 2.0 mg/dL, and serum creatinine = or < 2.0 mg/dL.
4. All men have agreed to use proper contraception during the entire FIT039-patch application period and for seven days after.
5. All women must satisfy one of the followings and have no possibility of being pregnant; in menopause, with 12 months or more having passed since the last menstruation without pathological reason, or having undergone permanent contraceptive surgery in the past, such as bilateral oophorectomy and bilateral ligation of the fallopian tubes.
6. Willing to participate in the study. Written informed consent has been obtained from the patient.
Key exclusion criteria
Men and women who meet the following criteria are excluded:
1. Allergic to transdermal patches.
2. Having one of the following complications: serious heart disease, gastrointestinal disease, liver disease, kidney disease, systemic skin disorders with lesions at the target verruca vulgaris, uncontrolled diabetes mellitus, infectious diseases requiring continuous treatment by injection or oral application of medical agents, or diseases requiring continuous systemic administration of immunosuppressants or steroids.
3. Having an active malignancy, excluding conditions such as, adequately treated basal cell carcinoma, intraepithelial carcinoma, or superficial bladder carcinoma, or a malignant tumor not showing metastasis or recurrence for 5 years or more from the end of treatment.
4. Having other verruca vulgaris warts within 1 cm from the target wart.
5. Having been treated with cryotherapy for the target wart within 4 weeks prior to the acquisition of written consent.
6. Taking general antiviral drugs within 4 weeks prior to the acquisition of the written consent.
7. Participating in other trials within 4 weeks prior to the acquisition of the written consent.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nomura |
Organization
Kyoto University Hospital
Division name
Department of dermatology
Zip code
606-8507
Address
Sakyo-ku
TEL
075-751-3310
kaba_@_kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nomura |
Organization
Kyoto University Hospital
Division name
Department of dermatology
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3310
Homepage URL
tnomura_@_kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
KinoPharma, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Shogoin-Kawahara-cho, Sakyo-ku
Tel
075-751-3111
None
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
京都大学医学部附属病院（京都府）
独立行政法人国立病院機構京都医療センター（京都府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 24 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 24 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033930
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