Healthy volunteers tinted sunscreen, visible light protection, immediate pigment darkening, Individual Typology Angle, iron oxide
Conditions
Interventions
Four investigational zones measuring 5x7 cm were marked on the mid-back region of each participant: one positive control zone (irradiated without product application), and three zones pre-treated with
Experimental Drug
Tinted sunscreen and broad-spectrum sunscreen
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Dermatological Society of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 18 years or older 2. Have a tan, brown, or dark skin tone, as assessed using the ITA (Individual Typology Angle) value of 10 to -40 measured with a colorimeter on the lower back area (the test site). 3. Can avoid sun exposure to the back area during the study period. 4. Can lie on their stomach continuously for at least 1 hour without any respiratory problems. 5. Can communicate effectively in Thai.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of sunbathing or excessive sun exposure to the back within the last month. 2. Individuals with a history of using photosensitizing agents, immunosuppressants, or anti-inflammatory medications within the last month. 3. Individuals with a history of laser treatment or artificial sunlight exposure to the back within the last 6 months. 4. Individuals with plans for any treatment or procedure on the back during the study period that may affect the results. 5. Individuals with photosensitivity, photosensitive rash, skin cancer, or skin conditions exacerbated by sunlight, such as systemic lupus erythematosus. 6. Individuals with open wounds, skin infections, or skin rashes on the back. 7. Individuals who are pregnant, breastfeeding, or within 3 months postpartum (as determined by menstrual history, contraception history, and physical examination by a physician). 8. Individuals with a history of allergy to sunscreen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visible light protection 15 minutes, 1 day, and 7 days post-irradiation colorimeter | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigators Global Assessment 15 minutes, 1 day, and 7 days post-irradiation Two independent physicians grading,Pigmentation assessments 15 minutes, 1 day, and 7 days post-irradiation colorimeter | — |
Countries
Thailand
Contacts
Public ContactYanisorn Nanchaipruek
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed