UMIN-CTR Clinical Trial

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
Email	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
Email	tnomura_@_kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Dermatology, Kyoto University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033930