UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032210 |
|---|---|
| Receipt number | 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 | 2020/10/12 09:23:11 |
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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 | 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
kamatsu@fujita-hu.ac.jp
Public contact
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
kamatsu@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
Fujita Health University School of Medicine
Address
1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
Tel
0562-93-2000
crb-f@fujita-hu.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
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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
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
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036315
