A preliminary safety study Cannabis, Cannabis extract-based feminine hygiene product, Feminine hygiene product
Conditions
Interventions
The trial was divided into 3 phases. Healthy female participants were enrolled in the study for a period of 6 weeks. When participants were recruited for the research project, the investigators applie
Experimental Other
Cannabis extract-based feminine hygiene product group
Sponsors
Faculty of Medicine, Thammasat University
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy women from 18-50 years old. 2. Women who are menstruating must receive advice on preventing pregnancy and use contraceptive devices to prevent pregnancy such as condoms, IUDs, etc., at least 14 days prior to the study and throughout the study period. Or, if using hormonal contraceptives, they must have been received at least 30 days prior to the trial and must continue using the same type of hormonal contraceptive during the trial period.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding 2. Women with congenital diseases that cause skin abnormalities such as atopy, psoriasis, vitiligo, or congenital diseases that cause skin abnormalities such as diabetes mellitus, porphyria. 3. Women with underlying diseases related to immune system disorders such as primary immunodeficiencies, HIV, anaphylaxis, asthma, generalized drug reactions, lymphoma, leukemia, rheumatoid arthritis, and systemic lupus erythematosus. 4. Women with a history of skin cancer such as melanoma, squamous cell carcinoma, etc., except superficial basal cell carcinoma, in a location that is not close to the test site. 5. Women who got immunosuppressants like cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic drugs, immunoglobulin, Bacillus Calmette-Guerin, monoclonal antibodies, radiation therapy, etc. during the three-week pre-trial period. 6. Women receiving oral antihistamine or some other medication were applied to the previous test site within 72 hours. 7. Women with different arm skin color or skin problems at the test site, such as excessive hair, scars, tattoos, open wounds, sunburn, punctures, or foreign objects inserted into the skin, etc., may interfere with the application of the test strip. interfere with interpretation or affect the skin irritation of the study participants. 8. Women who have menopause. 9. Women who are in other research projects 10. Women who are allergic to herbs or cannabis extracts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermal response Induction Phase: After removing the patch test immediately, 30 mins, 4 hours, and 24 hours. Challenge Phase : After removing the patch test immediately, 24 hours, and 48 hours. Dermal response scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Other effects Induction Phase: After removing the patch test immediately, 30 mins, 4 hours, and 24 hours. Challenge Phase : After removing the patch test immediately, 24 hours, and 48 hours. Other effects scoring scale | — |
Countries
Thailand
Contacts
Public ContactPratya Phetkate
Chulabhorn International College of Medicine, Thammasat University
Outcome results
None listed