skin irritation, cosmetic product safety, sunscreen efficacy, and user satisfaction in healthy human volunteers Sunscreen, Cosmetic safety, Healthy volunteers, Skin irritation, Sunscreen efficacy, User satisfaction, Cocoa butter, Corn silk extract
Conditions
Interventions
Apply 0.5 g of the treatment to one side of the face. Apply twice daily at 08 00 and 12 00 every day for 4 consecutive weeks.,Apply 0.5 g of the treatment to one side of the face. Apply twice daily at
Active Comparator Drug,Placebo Comparator No treatment
Sunscreen containing corn silk extract and cocoa butter,Control
Sponsors
National Research Council of Thailand (NRCT)
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age: twenty to forty years, male or female. 2. Skin condition: No wounds or infections on the inner forearm; any skin type (dry, oily, normal, or combination) is acceptable. 3. General health: Physically healthy with no immune-related chronic diseases (e.g., severe allergies). 4. Allergy history: No known allergies or sensitivities to cosmetic ingredients or test components. 5. Participants with a history of allergy to corn silk or corn-derived products (e.g., oral itching, rash, urticaria, facial/lip/tongue swelling, dyspnea, dizziness, nausea, vomiting, diarrhea, or anaphylaxis) will be excluded. 6. Pregnancy and lactation: Not pregnant or breastfeeding. 7. Willingness to participate: Able and willing to comply with study requirements and attend all follow-up sessions. 8. Informed consent: Signed informed consent form (ICF) obtained after full explanation of study objectives, procedures, and potential risks.
Exclusion criteria
Exclusion criteria: 1. Dermatological issues: Presence of psoriasis, eczema, wounds, redness, irritation, or infections at the test site. 2. Allergic history: Known hypersensitivity to corn silk, herbal extracts, or cosmetic ingredients used in the study. 3. Medication use: Use of topical or systemic medications affecting skin condition (e.g., corticosteroids, retinoids, or immunosuppressants) within 4 weeks prior to study initiation. 4. Pregnancy/lactation: Pregnant or breastfeeding individuals will be excluded due to potential hormonal effects on skin condition. 5. Concurrent studies: Currently participating in another clinical or cosmetic product trial. Physical/mental unsuitability: Any condition that could interfere with study participation or data reliability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema Assessments were conducted at 4 weeks after cream application arbitrary units | — |
Secondary
| Measure | Time frame |
|---|---|
| Melanin Index Assessments were conducted at 4 weeks after cream application arbitrary units | — |
Countries
Thailand
Contacts
Public ContactChutima Limmatvapirat
Faculty of Pharmacy, Silpakorn University
Outcome results
None listed