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

Not Applicable

Completed

• Conditions: Prevention of skin Damage in health Asian patients; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN15068483
• Lead Sponsor: INNOVATION LABO SCIENCES Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-20
• Study Start: 2023-08-10
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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)

Exclusion Criteria

1. Photosensitivity disorders
2. Condition and/or disease of the skin that the Investigator deems inappropriate for participation
3. Women who are nursing, pregnant, or planning to become pregnant during the study
4. Pre-existing or dormant dermatologic conditions which in the opinion of the Investigator could interfere with the outcome of the study
5. Regular consumption or application of any supplement (herbal, vitamin, etc)
6. Skin conditions including atopic dermatitis
7. Significant disease history of heart failure, dyslipidemia, diabetes, or uncontrolled hypertension
8. Risk of food allergy
9. Extreme skin condition changes caused by menstruation or irregular menstruation
10. Currently participating in another facial usage study or have participated in a clinical trial within 4 weeks prior to inclusion into the study
11. Planned surgeries and/or invasive medical procedures during the course of the study
12. Hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study
13. Facial sunburn or excessively tanned facial skin or that are not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study
14. Currently taking or have taken oral or topical probiotics or antibiotics within the last 30 days
15. Subjects having a history of psychiatric disorder that may impair the ability of subjects to provide written informed consent
16. Patients who have completed participation in any other clinical trial during the past 3 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary outcome measures are assessed from baseline to post-irradiation (Visit 4, Week 2, day 15) and baseline to week 8:<br>1. Minimum erythema dosage measured using a mexameter<br>2. Skin hydration level measured using a corneometer

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures are assessed from baseline to week 8:<br>1. Erythema Index measured using a mexameter<br>2. Salivary cortisol level measured using an enzyme-linked immunosorbent assay<br>3. Melanin index measured using a mexameter<br>4. Plasma total antioxidant status (TAS) measured using an enzyme-linked immunosorbent assay<br>5. Faecal short-chain fatty acids (SCFA) levels using measured using a gas chromatography analysis