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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032210
Receipt No. R000036315
Scientific Title A study on optimization of test substance application method for skin allergy test of hair color
Date of disclosure of the study information 2018/04/12
Last modified on 2018/04/12

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Basic information
Public title A study on optimization of test substance application method for skin allergy test of hair color
Acronym Optimization of skin allergy test of hair color
Scientific Title A study on optimization of test substance application method for skin allergy test of hair color
Scientific Title:Acronym Optimization of skin allergy test of hair color
Region
Japan

Condition
Condition Allergic contact dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is improvement of self test method which easily and accurately predicts severe hair color allergy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate the allergic contact dermatitis symptoms that appear after applying the hair color.
Time to applicate:
30 min, 3 hr, 24 hr, 48 hr
Time to evaluate allergic symptoms:
After 30 min, 3 hr, 6 hr, 12 hr, 24 hr, 48 hr, 72 hr, 96 hr, 1 week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Applying hair coloring agent (colorant, colorant(-dye), mixture of colorant & developer) to the skin of the subject's arm.
Hair color application time:
30 minutes, 3 hours, 24 hours, 48 hours
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. In participating in this research, patients who gain document consent by their own free will with sufficient understanding after having received sufficient explanation.
2. Patients between the age of 20 and under the age of 75 at the time of consent acquisition.
Key exclusion criteria 1.Patients who uses steroids or tacrolimus topical within a week for a test site
2.Patients who have been taking steroids over 20 mg of prednisolone.
3.Patients who have experienced anaphylaxis in hair coloring.
4. Patients who judged that the doctor in charge is inappropriate as the subject

Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kayoko Matsunaga
Organization Fujita Health University School of Medicine
Division name Department of Integrative Medical Science for Allergic Disease
Zip code
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL 0562-93-9441
Email kamatsu@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kayoko Matsunaga
Organization Fujita Health University School of Medicine
Division name Department of Integrative Medical Science for Allergic Disease
Zip code
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL 0562-93-9441
Homepage URL
Email kamatsu@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization JAPAN HAIR COLOR INDUSTRY ASSOCIATION
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 12 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 12 Day
Last modified on
2018 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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