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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023174
Receipt No. R000026714
Scientific Title Use test of makeup cosmetics to the skin disease patient
Date of disclosure of the study information 2016/07/15
Last modified on 2019/03/31

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Basic information
Public title Use test of makeup cosmetics to the skin disease patient
Acronym Use test of makeup cosmetics to the skin disease patient
Scientific Title Use test of makeup cosmetics to the skin disease patient
Scientific Title:Acronym Use test of makeup cosmetics to the skin disease patient
Region
Japan

Condition
Condition atopic dermatitis
contact dermatitis
acne vulgaris
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety (5 % or less side effects rate) when using 4 weeks makeup cosmetics such as foundation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes A scoring (pear: 0 points, slight :1 and slightness: 2 points and the degree of middle class: 3 points are serious: 4 points) does the degree of the cutaneous symptom in each observation item of the skin view. When or there are more than 2 items which did more than 1 outbreak when there is more than 1 item which did more than 2 outbreaks before and after a test in a change in the cutaneous symptom by which a doctor in attendance judges that there is causality with this research items, I judge "It has side effects."
Further, when an outbreak of the cutaneous symptom is more than 2 and cause test items can't be specified, study director's judgement and fixation which depends on patch test when object's consent is got, are performed.
Key secondary outcomes The movement observation, the questionnaire and the QOL investigation by which inspection of safety: is inflammations in the epidermis horny layer and cytokines of a hyperkeratosis, etc.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Make-up cosmetics is replaced with study items.
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 Female
Key inclusion criteria More than 20-year-old female with the next one of diseases. I make the person who hopes for make-up to a face the subject.
・Atopic dermatitis
・Contact dermatitis
・Acne
Further, an object makes sure that it's diagnosed as an atopic dermatitis based on definition of an atopic dermatitis "and" criterion of Japanese Dermatological Association and that the stimulator which was diagnosed as a contact dermatitis based on a contact dermatitis medical examination and treatment guideline and caused and an antigen are specified with the person by whom vulgarity za is diagnosed as a rash based on "a vulgarity,za rash treatment guideline".
Key exclusion criteria ・The person who has the experience which has caused the serious cutaneous symptom by use of make-up cosmetics in the past
・Person with the tetter unsuitable for application of the final examination items in an application part
・When intervention of other treatment external preparation and final examination items is expected.
・The person who can't examine it 4 weeks later (as principle)
・Additionally the person by whom a doctor in attendance judges participation in this research with unsuitableness
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Makiko
Middle name
Last name Nakahara
Organization Kyusyu University
Division name Department of Dermatology, Graduate School of Medical Sciences
Zip code 812-0054
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL 092-642-5596
Email macky@dermatol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Makiko
Middle name
Last name Nakahara
Organization Kyusyu University Hospital
Division name Dermatology
Zip code 812-0054
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL 092-642-5596
Homepage URL
Email macky@dermatol.med.kyushu-u.ac.jp

Sponsor
Institute Kyusyu University Hospital
Institute
Department

Funding Source
Organization Tokiwa Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyusyu University Hospital Certified Review Board
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
Tel 092-642-5774
Email bynintei@jimu.kyushu-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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 15 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 31
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
2016 Year 07 Month 21 Day
Date of IRB
2016 Year 07 Month 21 Day
Anticipated trial start date
2016 Year 07 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 14 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026714

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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