Comparative trial on the effectiveness of topical cannabidiol based on different adhesion times in healthy individuals.

JRCT ID: jRCT1031230303

Registered date:22/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy people
• Date of first enrollment: 01/09/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Apply a cannabidiol-containing non-woven fabric and a placebo to each side of the face for 10 and 20 minutes respectively.

Outcome(s)

• Primary Outcome: Changes in trans-epidermal water loss
• Secondary Outcome: Changes in stratum corneum hydration, skin elasticity, sebum amount, skin surface pH, melanin and erythema levels, skin texture evaluation, skin surface gloss measurement, skin friction measurement, skin color measurement, dermis measurement, skin image analysis, changes in skin vascular evaluation measurements, changes in stratum corneum cytokine levels, and changes in measurements of corneocyte desquamation.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 50age old
• Gender: Both

Include criteria

1. Healthy males and females aged 20 to less than 50 years
2. Patients who have not used CBD supplements or CBD cosmetics within the four weeks prior to consent
3. Patients who can practice the instructed usage on their own
4. Patients who have not received other beauty treatments or procedures (such as hyaluronic acid injections, silicon injections, botox, thread lifts, HIFU, etc.) or any surgical treatment on the face within two weeks prior to the start of the study
5. Patients who can go to the outpatient clinic according to the study implementation schedule
6. Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study

Exclude criteria

1. Patients who have experienced hypersensitivity or contact dermatitis due to the ingredients used in this study or similar ingredients
2. Patients who have inappropriate rashes or other skin conditions at the intended site of application for the trial product
3. Patients who have inflammation or wounds on the face
4. Patients who are currently pregnant or breastfeeding
5. Patients who have a malignant tumor (however, this does not apply if it has been cured through surgery or other treatments)
6. Patients who have significantly different skin conditions or symptoms on both sides of their face
7. Patients who are currently participating in other clinical trials or research studies
8. Patients who the principal investigator has deemed unsuitable for the study

Related Information

• Primary Sponsor: Yoshizaki Ayumi