UMIN-CTR Clinical Trial

Public title

Study on Establishment of Allergy Confirmation Method for Cosmetics and others

Acronym

Study on Establishment of Allergy Confirmation Method for Cosmetics and others

Scientific Title

Study of concentration base of patch test/prick test

Scientific Title:Acronym

patch test/prick test

Region

Japan

Condition

Contact dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study, in order to speed up the investigation of the cause when a new adverse event occurs in the future, we conduct epidemiological studies of case information on adverse events that occurred in quasi-drugs, cosmetics etc.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Investigate and analyze defect cases in skin and body such as contact dermatitis in Japan.

Key secondary outcomes

1.Search for harmful cases
2.Sensitization rate of contact dermatitis allergens
3.Number of cases by region
4.Number of occupational skin disorder cases
5.Comparison with past data

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Implement patch test

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Object
Allergy / photoallergic contact dermatitis, allergic contact urticaria (syndrome), protein contact dermatitis, immediate allergy by ingestion, irritant / irritant / allergic contact erythema (syndrome) due to products and chemical substances used routinely such as cosmetics, Understanding the purpose of this research and notifying the applicant in written form, in patients who are suffering skin and body disorders such as phototoxic contact dermatitis, vitiligo / depigmenting plaques, chemical burns, etc., satisfying certain qualification criteria and not meeting exclusion criteria Children aged (under 20 years old) and adults (over 20 years old)
Selection criteria
1) Patients should have skin disorder induced by any substance / product applied / contacted to the skin.
2) Be patient who is willing to comply with the research implementation plan.
3) Sign the consent form approved by the Ethics Review Committee of the medical institution conducting the trial
about.

Key exclusion criteria

A patient whose research doctor judges that participation in research is inappropriate

Target sample size

1000

Name of lead principal investigator

1st name	Kayoko
Middle name
Last name	Matsunaga

Organization

Fujita Health University School of Medicine

Division name

Department of Integrative Medical Science for Allergic Disease

Zip code

470-1192

Address

1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192

TEL

0562-93-9441

Email

kamatsu@fujita-hu.ac.jp

Name of contact person

1st name	Kayoko
Middle name
Last name	Matsunaga

Organization

Fujita Health University School of Medicine

Division name

Department of Integrative Medical Science for Allergic Disease

Zip code

470-1192

Address

1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192

TEL

0562-93-9441

Homepage URL

Email

kamatsu@fujita-hu.ac.jp

Institute

Fujita Health University School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fujita Health University School of Medicine

Address

1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192

Tel

0562932865

Email

f-irb@fujita-hu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

01

Month

25

Day

Date of IRB

2014

Year

07

Month

31

Day

Anticipated trial start date

2014

Year

07

Month

31

Day

Last follow-up date

2015

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2016

Year

10

Month

31

Day

Other related information

Registered date

2018

Year

08

Month

29

Day

Last modified on

2019

Year

08

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038675