UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042977 |
|---|---|
| Receipt number | 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 | 2021/03/23 21:48:11 |
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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
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
nuchida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Department of Clinical Pharmacology
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
In the range of CBD concentrations of 0% to 1.5%, CBD was not observed of any skin irritating adverse effects.
Results date posted
| 2021 | Year | 03 | Month | 23 | Day |
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
Main results already published
Date of protocol fixation
| 2021 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
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 | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049067
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
