Unique ID issued by UMIN | UMIN000019866 |
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Receipt number | R000022948 |
Scientific Title | Phase I/II study on the safety and pharmacokinetics of FIT039 administered by single adhesive skin patch application for the cases of human papillomavirus verrucae |
Date of disclosure of the study information | 2016/03/31 |
Last modified on | 2020/08/18 13:52:54 |
Phase I/II study on the safety and pharmacokinetics of FIT039 administered by single adhesive skin patch application for the cases of human papillomavirus verrucae
On the safety and pharmacokinetics of FIT039
Phase I/II study on the safety and pharmacokinetics of FIT039 administered by single adhesive skin patch application for the cases of human papillomavirus verrucae
On the safety and pharmacokinetics of FIT039
Japan |
Verruca vulgaris
Dermatology |
Others
NO
To evaluate the safety, pharmacokinetics in peripheral blood, and efficacy of FIT039 delivered by single application of adhesive skin patch on the normal back skin and verruca vulgaris lesion, which is pre-treated with cryotherapy
Safety
Exploratory
Others
Phase I,II
Adverse and side effects at 30 minutes, 2 hours, 4 hours, 1 day, and 7 days after the intervention
Frequency of adverse events and side effects for each undesirable event Kinetics of FIT039 concentration in peripheral blood
Surface area of verruca vulgaris lesion Changes of vital signs
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Single application of adhesive skin patch containing FIT039
20 | years-old | <= |
Not applicable |
Male and Female
1. V erruca vulgaris developed on extremities and scheduled to be treated with cryotherapy
2. Women,who have no possibility for pregnancy and suffice one of the followings; that being aged 60 years or more at the time of issuing informed consent, that being elapsed more than 12 months from the last menstrual and determined to be menopausal, or that being operated with bilateral oophorectomy
3. The latest laboratory data, given within four weeks prior to the enrollment, sufficing the following; hemoglobin >= 8 g/dL, white blood cells >= 2,000/dL, platelets >= 70,000/dL, AST (GOT) <= 100 IU/L, ALT (GPT) <= 100 IU/L, total bilirubin <= 1.5 mg/dL, serum creatinine <= 2.0 mg/dL
4. Written consent with respect to the participation in this study is obtained from the patient himself or herself
1. One who has allergy to adhesive skin patch
2. One who has at least one of the complications as follows: severe complications of heart disease, respiratory disease, gastrointestinal disease, liver disease, or renal disease; dermal diseases except atopic dermatitis and verruca vulgaris; poorly controlled diabetes mellitus; infection requiring continuous treatment; diseases that require systemic administration of immunosuppressant or steroids
3. Carrying malignancy in an active state
4. Taking antiviral agent within four weeks prior to the time of obtaining informed consent
5. Being enrolled in other clinical study within four weeks prior to the time of obtaining informed consent
6. Any patient, who was determined by the principal investigator or the physician in charge to be inadequate safely to conduct the present study
9
1st name | Kenji |
Middle name | No middle name |
Last name | Kabashima |
Kyoto University Hospital
Department of Dermatology
606-8507
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
075-751-3310
kenji@kuhp.kyoto-u.ac.jp
1st name | Takashi |
Middle name | None |
Last name | Nomura |
Kyoto University Hospital
Department of Dermatology
606-8507
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
075-751-3310
tnomura@kuhp.kyoto-u.ac.jp
Department of Dermatology, Kyoto University Hospital
Department of Anatomy and Developmental Biology, Kyoto University Faculty of Medicine
Translational Research Network Program
Japanese Governmental office
N/A
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
京都大学医学部附属病院(京都府)
Kyoto University Hospital (Kyoto Prefecture)
2016 | Year | 03 | Month | 31 | Day |
https://doi.org/10.1007/s40261-018-0712-7
Published
https://doi.org/10.1007/s40261-018-0712-7
11
FIT039 patch produced no topical or systemic adverse reactions.
2020 | Year | 08 | Month | 14 | Day |
2018 | Year | 10 | Month | 05 | Day |
Aged 20 years or older men or women with cutaneous warts, measuring 4-10 mm on the major axis and located on the extremities.
Individuals who had an allergy to adhesive skin patches, had severe complications, had taken antiviral agents within 4 weeks prior to giving informed consent, and women who could become pregnant.
Participants gave informed consent, were taken blood for screening exclusion criteria, and were applied with FIT039 or placebo dermal patches.
A total of three adverse events, including herpes simplex infection, pain, and contact dermatitis at a site other than the trial patch application site were reported, and all were classed as non-serious and unrelated to the trial treatment.
The incidence of adverse events and adverse drug reactions such as dermatitis of the sites applied with transdermal patches and any other events including anaphylaxis, change of blood pressure, change of blood counts, change of hepatic and renal function.
Not planned.
Not planned
Completed
2015 | Year | 11 | Month | 20 | Day |
2016 | Year | 02 | Month | 10 | Day |
2016 | Year | 07 | Month | 14 | Day |
2017 | Year | 04 | Month | 26 | Day |
2017 | Year | 04 | Month | 26 | Day |
2017 | Year | 06 | Month | 28 | Day |
2017 | Year | 09 | Month | 08 | Day |
2015 | Year | 11 | Month | 19 | Day |
2020 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022948
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