A study to evaluate the effect of Phenixun Shield® supplementation in UV radiation protection in Asian subjects

INTERVENTION: Randomization: Block randomization is used to divide potential patients into m blocks of size 2n, randomize each block such that n patients are allocated to A and n to B then choose the blocks randomly. This method ensures equal treatment allocation within each block if the complete block is used. Administration: Patients are asked to take Phenixun Shield® (250 mg in capsules) in the intervention group or placebo (dextrin 3g in a stick) in the control group orally in the morning before breakfast for 4 weeks. Products are to be taken directly in the mouth with a glass of water. There are a total of 7 study visits. At each visit, the skin is exposed to ultraviolet light using a solar simulator that provides illumination reproducing natural sunlight. The schedule of visits and measurements: Visit 1, Week 0, Day 1: During the first visit, all baseline values are measured (hydration, transepidermal water loss (TEWL), erythema index, melanin index, plasma total antioxidant status (TAS), salivary cortisol levels, and faecal short‐chain fatty acids (SCFA) levels). Skin Irradiation for the minimal erythema dose (MED) evaluation is done during the first visit. Visit 2, Week 0, Day 2: MED evaluation will be done 24 hrs after skin Irradiation. Visit 3, Week 2, Day 14: After 2 weeks of placebo/Phenixun intake, the inside of the right upper arm will be irradiated with 1.5 MED of UV. Visit 4, Week 2, day 15: After 24 hours of 1.5 MED skin Irradiation, post‐irradiation values of skin hydration, TEWL, erythema index, and salivary cortisol levels will be measured. These measurements will help to evaluate how well the test product supplementation helped to prevent UVR damage on the skin. Visit 5, Week 4, Day 28: Skin hydration, TEWL, erythema index, and salivary cortisol level measur CONDITION: Prevention of skin Damage in health Asian patients ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: The following primary outcome measures are assessed from baseline to post‐irradiation (Visit 4, Week 2, day 15) and baseline to week 8:; 1. Minimum erythema dosage measured using a mexameter; 2. Skin hydration level measured using a corneometer SECONDARY OUTCOME: The following secondary outcome measures are assessed from baseline to week 8:; 1. Erythema Inde Xmeasured using a mexameter; 2. Salivary cortisol level measured using an enzyme‐linked immunosorbent assay; 3. Melanin inde Xmeasured using a mexameter; 4. Plasma total antioxidant status (TAS) measured using an enzyme‐linked immunosorbent assay; 5. Faecal short‐chain fatty acids (SCFA) levels using measured using a gas chromatography analysis INCLUSION CRITERIA: 1. Healthy non‐smoker Asian female subjects between aged 25 and 55 years (inclusive) old 2. Fitzpatrick skin type II ‐ IV 3. Individuals of childbearing potential use an acceptable method of contraception throughout the study 4. Subjects must be stable on any medication they are taking for at least 30 days 5. Willing to give written informed consent and willing to comply with the trial protocol 6. Ability to understand the risks/benefits of the protocol 7. Subject should be available for the duration of the study period (8 weeks)