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Skin irritation patch test to evaluate skin safety of Cannabidiol (CBD) in healthy Female subjects

Skin irritation patch test to evaluate skin safety of Cannabidiol (CBD) in healthy Female subjects - Cannabidiol patch test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042977
Enrollment
10
Registered
2021-02-15
Start date
2021-02-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Female

Interventions

CBD concentration 0% CBD concentration 0.1% CBD concentration 0.5% CBD concentration 1.0% CBD concentration 1.5% unit only

Sponsors

Showa University School of Medicine Department of Clinical Pharmacology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Assessment of skin irritation based on the ICDRG (International Contact Dermatitis Research Group) Standards

Secondary

MeasureTime frame
Safety: Evaluated for all adverse events

Countries

Japan

Contacts

Public ContactUchida Naoki

Showa University School of Medicine Department of Clinical Pharmacology

nuchida@med.showa-u.ac.jp0333005254

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026