Testing of visible light protection factor and irritation potential of a novel sunscreen formulation containing ORYZA SATIVA bran extract Sunscreen Visible light ORYZA SATIVA
Conditions
Interventions
Test visible light protection factor and skin irritation test of novel sunscreen on human volunteer
Experimental Other
Sunscreen
Sponsors
Department of Dermatology, Siriraj Hospital
S&
J International Enterprises Public Company Limited
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Study 1 Evaluation of Visible Light Protection Efficacy 1 Healthy volunteers aged 18 years and older 2 Individuals with tan, brown, or dark skin, as determined by an Individual Typology Angle ranging from 10 to minus 40, measured using a colorimeter at the lower back area designated for testing 3 Able to avoid sun exposure on the back area throughout the study period. 4 Able to lie in a prone position continuously for at least one hour without any respiratory issues. Study 2 Irritation Assessment 1 Healthy volunteers aged 18 to 60 years 2 Individuals with fair to medium skin tones, Fitzpatrick skin types I to IV 3 Able to wear a patch test on the upper arm for 4 hours 4 Able to refrain from exercise during the test period, ensure the patch test area remains dry, and avoid applying any creams or topical medications to the test site 5 Able to attend scheduled follow up visits for patch reading at 24,48 hours
Exclusion criteria
Exclusion criteria: Study 1: Evaluation of Visible Light Protection Efficacy 1. History of sunbathing or intense sun exposure on the back area within the past month. 2. Use of photosensitizing agents, immunosuppressive drugs, or antiinflammatory medications within the past month. 3. History of laser treatment or artificial light exposure e.g., tanning devices on the back within the past 6 months. 4. Planned medical treatments or procedures on the back during the study period that could affect the results. 5. History of photosensitivity disorders, photodermatitis, skin cancer, or photosensitive dermatoses such as systemic lupus erythematosus. 6. Open wounds, skin infections, or active rashes on the back area. 7. Presence of underlying medical conditions affecting the immune system, including 7.1. Congenital or acquired immunodeficiency, such as HIV or AIDS 7.2. Allergic diseases, such as severe anaphylaxis, asthma, or generalized drug reactions 7.3. Malignancies, including lymphoma or leukemia 7.4. Autoimmune diseases, such as rheumatoid arthritis or systemic lupus erythematosus 8. Use of immunosuppressive medications within the past 3 weeks, including cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic agents, immune globulin, Bacillus Calmette Guerin immunotherapy, or monoclonal antibodies 8. Currently pregnant, breastfeeding, or within 3 months postpartum based on menstrual history, contraceptive use, and medical examination 9. Known allergy to sunscreen ingredients 10. Inability to read or communicate in the Thai language Study 2: Irritation Assessment 1. Currently pregnant, breastfeeding, or within 3 months postpartum based on menstrual history, contraceptive use, and medical examination 2. Known allergy to sunscreen ingredients or skincare products 3. Dermatitis, wounds, skin infections, scars, or tattoos at the test site 4. Presence of underlying medical conditions affecting the immune system, including 4.1. Congenital or acquired immunodeficiency, such as HIV or AIDS 4.2. Allergic diseases, such as severe anaphylaxis, asthma, or generalized drug reactions 4.3. Malignancies, including lymphoma or leukemia 4.4. Autoimmune diseases, such as rheumatoid arthritis or systemic lupus erythematosus 5. Use of immunosuppressive medications within the past 3 weeks, including cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic agents, immune globulin, Bacillus Calmette Guerin immunotherapy, or monoclonal antibodies 6. Phototherapy at the test site within the past 3 weeks 7. Radiation therapy at the test site within the past 3 weeks 8. Use of antihistamines within 72 hours prior to testing 9. Inability to read or communicate in the Thai language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visible light protection factor 7 days pigment darkening of skin | — |
Secondary
| Measure | Time frame |
|---|---|
| Irritancy test 2 days patch test | — |
Countries
Thailand
Contacts
Public ContactWoraphong Woraphong
Siriraj Hospital
Outcome results
None listed