UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019866
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

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Basic information

Public 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

Acronym

On the safety and pharmacokinetics of FIT039

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

Scientific Title:Acronym

On the safety and pharmacokinetics of FIT039

Region

Japan


Condition

Condition

Verruca vulgaris

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase I,II


Assessment

Primary outcomes

Adverse and side effects at 30 minutes, 2 hours, 4 hours, 1 day, and 7 days after the intervention

Key secondary outcomes

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


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

Single application of adhesive skin patch containing FIT039

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


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

9


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name No middle name
Last name Kabashima

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

Email

kenji@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name None
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 or person

Institute

Department of Dermatology, Kyoto University Hospital
Department of Anatomy and Developmental Biology, Kyoto University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Translational Research Network Program

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

N/A


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

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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

京都大学医学部附属病院(京都府)
Kyoto University Hospital (Kyoto Prefecture)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 31 Day


Related information

URL releasing protocol

https://doi.org/10.1007/s40261-018-0712-7

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s40261-018-0712-7

Number of participants that the trial has enrolled

11

Results

FIT039 patch produced no topical or systemic adverse reactions.

Results date posted

2020 Year 08 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2018 Year 10 Month 05 Day

Baseline Characteristics

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.

Participant flow

Participants gave informed consent, were taken blood for screening exclusion criteria, and were applied with FIT039 or placebo dermal patches.

Adverse events

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.

Outcome measures

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.

Plan to share IPD

Not planned.

IPD sharing Plan description

Not planned


Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 11 Month 20 Day

Date of IRB

2016 Year 02 Month 10 Day

Anticipated trial start date

2016 Year 07 Month 14 Day

Last follow-up date

2017 Year 04 Month 26 Day

Date of closure to data entry

2017 Year 04 Month 26 Day

Date trial data considered complete

2017 Year 06 Month 28 Day

Date analysis concluded

2017 Year 09 Month 08 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 19 Day

Last modified on

2020 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022948


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name