A study to evaluate the effect of Phenixun Shield® supplementation in UV radiation protection in Asian subjects
| ISRCTN | ISRCTN15068483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15068483 |
| Secondary identifying numbers | SE/INNOVATIONLABO 22-0528 |
- Submission date
- 17/07/2023
- Registration date
- 10/08/2023
- Last edited
- 25/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
UV radiation can cause different acute and chronic effects on the skin. Phenixun Shield® is proposed to be a superior anti-oxidant supplement with unique photo-protective abilities because it contains multiple active ingredients that contribute to its superior skin protective efficacy through various molecular mechanisms. Previous in vitro studies have suggested the efficacy of this product in reducing UV damage, oxidative stress and cortisol production. The present study is designed to test the efficacy of Phenixun Shield® in various parameters that indicate the status of photoprotection and oxidative stress.
Who can participate?
Healthy non-smoker Asian female subjects aged between 25 and 55 years old (inclusive) with Fitzpatrick skin type II-IV
What does the study involve?
Participants will be randomly assigned to a once-daily Phenixun Shield® supplement or a placebo/dummy supplement for 8 weeks.
What are the possible benefits and risks of participating:
Possible benefits are an improvement in skin health. No risks are expected.
Where is the study run from?
INNOVATION LABO Sciences Co., Ltd (Japan)
When is the study starting and how long is it expected to run for?
June 2022 to June 2023
Who is funding the study?
INNOVATION LABO Sciences Co., Ltd (Japan)
Who is the main contact?
Dr Yuki Ikeda, development@innovationlabo.com (Japan)
Contact information
Scientific
INNOVATION LABO SCIENCES Co., Ltd
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
 ORCID ID |
0000-0001-6067-4574 |
|---|---|
| Phone | +81 (0)3-35525335 |
| development@innovationlabo.com |
Study information
| Study design | Interventional double-blind placebo-controlled single-center randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Laboratory |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Double-blind placebo-controlled clinical study to evaluate the effect of supplementation with Phenixun Shield® during 8 weeks on skin protection immediately after exposure to ultraviolet radiation in Asian subjects |
| Study acronym | PhenixunUV |
| Study objectives | Phenixun Shield® is more efficient than a placebo to decrease skin damage after exposition to UV radiation |
| Ethics approval(s) |
Approved 12/12/2022, Japanese Society of Anti-Aging Nutrition (JAAN) (Ginza, Chuo-ku, Tokyo, 104-0061, Japan; +81 3 3552 5277; coordinator@jaan.jp), ref: ILOS22395-G133 |
| Health condition(s) or problem(s) studied | Prevention of skin Damage in health Asian patients |
| 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 measurements will be repeated at week 4 to understand the efficacy of the test product in recovery after UV irradiation. Visit 6, Week 8, Day 56: At week 8, outcome measures such as hydration, TEWL, erythema index, melanin index, plasma TAS, salivary cortisol levels, and faecal SCFA levels will be evaluated again. Skin irradiation will be repeated for the end-of-study evaluation of MED. Visit 7, Week 8, Day 57: MED evaluation will be repeated for end-of-study measurement. |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | The following secondary outcome measures are assessed from baseline to week 8: 1. Erythema Index measured using a mexameter 2. Salivary cortisol level measured using an enzyme-linked immunosorbent assay 3. Melanin index measured 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 |
| Overall study start date | 01/06/2022 |
| Completion date | 20/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 15/02/2023 |
| Date of final enrolment | 26/03/2023 |
Locations
Countries of recruitment
- France
Study participating centre
Annecy
74000
France
Sponsor information
Industry
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
| Phone | +81 (0)3-35525335 |
|---|---|
| tokyo@innovationlabo.com | |
| Website | https://www.innovationlabo.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Yuki Ikeda, development@innovationlabo.com. Individual participant data in an anonymous format will be shared upon publication of results and for a period of 2 years. Consent from participants is required and obtained. |
Editorial Notes
25/07/2023: Trial's existence confirmed by the Ethics Review Committee of the Japanese Society of Anti-Aging Nutrition (JAAN) (Japan).
