Skin irritation, cosmetic product safety, and user satisfaction in healthy human volunteers. Skin care, Cosmetic safety, Healthy volunteers, Skin irritation, User satisfaction, Cocoa butter, Cocoa seed shell extract
Conditions
Interventions
The amount of cream applied to each inner forearm is 0.3 g, applied twice daily (morning and before bedtime) after bathing, continuously for 7 days.,The amount of cream applied to each inner forearm i
Active Comparator Drug,Placebo Comparator No treatment
cocoa skin cream,cream base
Sponsors
National Research Council of Thailand (NRCT)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age: Volunteers age eighteen to sixty years, both female and male. Skin condition: No wounds or infections at the test area (inner forearm); participants with dry, oily, normal, or combination skin are acceptable. General health: Must be in good physical health, without chronic conditions related to the immune system, including severe allergies. Medication use: No topical or oral medications that may affect skin condition, including steroids, retinoids, or immunosuppressants, within 4 weeks prior to the study. Pregnancy or breastfeeding: Volunteers who are pregnant or breastfeeding are not accepted due to potential hormonal and skin condition effects. Participation in other trials: Not currently participating in other product trials during the same period. Unsuitable physical or mental condition: No chronic diseases or mental health issues that may interfere with study participation or adherence to protocol. Allergy history: No known allergies to any ingredients in the test product. Willingness to participate: Able and willing to participate in the study and comply with study procedures, including attending follow-up visits as scheduled. Informed consent: Signed the informed consent form after receiving information regarding study objectives, procedures, and potential risks.
Exclusion criteria
Exclusion criteria: Skin conditions: Presence of skin diseases such as psoriasis, atopic dermatitis, wounds, peeling skin, or infections at the area of skin to be tested. Allergy history: History of allergy or irritation to general cosmetic products or to any ingredients in the test product (cocoa butter or cocoa seed coat extract).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| erythema After using the cream: at 3 days and 7 days, respectively. arbitrary units | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction After using the cream: at 3 days and 7 days, respectively. satisfaction level | — |
Countries
Thailand
Contacts
Public ContactChutima Limmatvapirat
Faculty of Pharmacy, Silpakorn University
Outcome results
None listed