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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042977
Receipt No. R000049067
Scientific Title Skin irritation patch test to evaluate skin safety of Cannabidiol (CBD) in healthy Female subjects
Date of disclosure of the study information 2021/02/15
Last modified on 2021/01/12

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Basic information
Public title Skin irritation patch test to evaluate skin safety of Cannabidiol (CBD) in healthy Female subjects
Acronym Cannabidiol patch test
Scientific Title Skin irritation patch test to evaluate skin safety of Cannabidiol (CBD) in healthy Female subjects
Scientific Title:Acronym Cannabidiol patch test
Region
Japan

Condition
Condition Health Female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the skin safety of CBD with skin irritation patch test in healthy female subject.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of skin irritation based on the ICDRG (International Contact Dermatitis Research Group) Standards
Key secondary outcomes Safety: Evaluated for all adverse events

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 CBD concentration 0%
Interventions/Control_2 CBD concentration 0.1%
Interventions/Control_3 CBD concentration 0.5%
Interventions/Control_4 CBD concentration 1.0%
Interventions/Control_5 CBD concentration 1.5%
Interventions/Control_6 unit only
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
55 years-old >=
Gender Female
Key inclusion criteria 1) Female between the Age from 20<= <45 at the time of obtaining consent
2) Those who have the ability to consent, comply with matters to be complied with while participating in the examination, undergo the pre-examination stipulated in this test implementation plan, and can declare subjective symptoms, etc.
3) Those who do not have skin diseases such as dermatitis and eczema at the site where study drug will be administered
4) A person who has no history of rashes caused by bandages and contact dermatitis caused by metal, cosmetics, household products, etc.
5) Those who have a BMI (Body Mass Index) of 18.5 or more and 30.0 or less at the time of screening visit
Key exclusion criteria ) Those who have a history of evaluation of this test and considered to have an impact on safety, such as Drug abuse/ dependence, alcohol abuse/ dependence, heart, liver, kidney, lung, eye, blood, digestive diseases, etc.
2) A person who has a history of allergies to drugs or has a specific constitution (Alcohol hypersensitivity, etc.)
3) Those who may use the drug (antihistamines, adrenal cortical hormone agents) within one week before administered the study drug
4) Pregnant or nursing women
5) Those who are within 3 months of participating in other clinical trials
6) In addition, those who are deemed unsuitable for this study by the physician responsible for the research or the doctor sharing the research
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Uchida
Middle name
Last name Naoki
Organization Showa University School of Medicine
Division name Department of Clinical Pharmacology
Zip code 157-8577
Address 6-11-11 Kitakarasuyama Setagaya-ku, Tokyo
TEL 0333005254
Email nuchida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Uchida
Middle name
Last name Naoki
Organization Showa University School of Medicine
Division name Department of Clinical Pharmacology
Zip code 157-8577
Address 6-11-11 Kitakarasuyama Setagaya-ku, Tokyo
TEL 0333005254
Homepage URL
Email nuchida@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Department of Clinical Pharmacology
Institute
Department

Funding Source
Organization Japan Cosmetics Association
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 IRB of Showa Univ. Karasuyama Hospital
Address 6-11-11 Kitakarasuyama
Tel 0333005247
Email kawashima@ofc.showa-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
2021 Year 02 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
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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 12 Day
Last modified on
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049067

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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