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Comprehensive Evaluation of the Visible Light Protection and Irritation Potential of a Novel Sunscreen Formulation Containing ORYZA SATIVA Bran Extract

Comprehensive Evaluation of the Visible Light Protection and Irritation Potential of a Novel Sunscreen Formulation Containing ORYZA SATIVA Bran Extract

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260627008
Enrollment
10
Registered
2026-06-27
Start date
2026-03-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visible light protection factor of Oryza Sativa Tinted sunscreen, Visible light protection, Hyperpigmentation, Individual Typology Angle, Ultraviolet A1

Interventions

TINTED TONE UP UV SUNSCREEN SPF50 PA+++ (SKY020-03) - light shade tinted sunscreen,TINTED TONE UP UV SUNSCREEN SPF50 PA+++ (SKY021-04)-light shade tinted sunscreen,TINTED TONE UP UV SUNSCREEN SPF50 PA

Sponsors

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers aged 18 years or older 2. Having tan, brown, or dark skin types, evaluated using an Individual Typology Angle (ITA) value ranging from 10 to -40 measured by a Colorimeter at the lower back (the designated test site).Able to avoid sun exposure on the back area throughout the duration of the research study. - Able to lie in a prone position continuously for at least 1 hour without any respiratory issues.

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of sunbathing or intense sun exposure on the back within 1 month prior to the study. 2. Individuals with a history of using photosensitizing agents, immunosuppressants, or anti-inflammatory drugs within 1 month prior to the study. 3. Individuals with a history of laser treatment or artificial UV phototherapy on the back within 6 months prior to the study. 4. Individuals with plans to undergo any medical treatments or procedures on the back during the study period that could affect the interpretation of the results. 5. Individuals with a history of photosensitivity disorders, photodermatoses, skin cancer, or skin diseases exacerbated by sunlight. 6. Individuals with open wounds, skin infections, or active rashes/dermatitis on the back area. 7. Individuals with underlying medical conditions that affect the immune system. 8. Individuals who have used medications affecting the immune system within 3 weeks prior to the study. 9. Individuals who are currently pregnant, breastfeeding, or less than 3 months postpartum Individuals with a known history of allergy to sunscreen ingredients. 10. Individuals who are unable to read or communicate effectively in the Thai language.

Design outcomes

Primary

MeasureTime frame
ITA by colorimeter baseline, 15 min, day1, day2, day3, day4, day7 Colorimeter,Reaction after 24 hr occlusive patch test day1, day2 dermatologist according to the Cosmetic, Toiletry, and Fragrance Association (CTFA) guideline.

Secondary

MeasureTime frame
IGA for hyperpigmentation baseline, 15 min, day1, day2, day3, day4, day7 physician

Countries

Thailand

Contacts

Public ContactWoraphong Manuskiatti

Faculty of medicine, Siriraj hospital

woraphong.man@mahidol.ac.th024194333

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026