Randomized and Double-blinded Study Designed to Evaluate and Compare the Efficacy of a Once a Day Dietary Supplement to Reduce the Appearance of Wrinkles and Uneven Skin Tone and to Diminish the Appearance of Fine Lines and Wrinkles, to Affect Skin Complexion and Texture and to Strengthen the Skin Barrier, Over the Course of a 12-week Use Period, and 2 Weeks Post Usage
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Skin
- Sponsor
- LycoRed Ltd.
- Locations
- 1
- Primary Endpoint
- VISIA-CR® images of each subject's face
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate perceived changes in skin health and appearance after taking the study product daily for 12 weeks. The study product is a soft gel supplement containing tomato oil. cored Lumenato supplement on skin health and appearance.
Detailed Description
This is a pilot study, randomized and double-blinded designed to evaluate and compare the efficacy of a once a day dietary supplement to reduce the appearance of wrinkles and uneven skin tone and to diminish the appearance of fine lines and wrinkles, to affect skin complexion and texture and to strengthen the skin barrier, over the course of a 12-week use period, and 2 weeks post usage. Randomization at 1:1 ratio and is done by the sponsor. The product will arrive blinded (with the kit number stated on the label) neither subjects nor study staff will know the identity of the test products. A sequential number of bottles will be assigned to every enrolled subject.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Participants with Fitzpatrick skin types of 1, 4, 5 or 6
- •Known allergies or sensitivity to tomato, latex and/or potato
- •Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
- •Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as \>10 consecutive days
- •Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
- •Pregnant, lactating or breastfeeding women (within the last 6 months) or those planning to become pregnant during the study period
- •Less than 2 years since diagnosis or treatment of skin cancer including basal cell carcinoma, squamous cell carcinoma, melanoma- excluding actinic keratosis
- •Currently active herpes infections or currently on treatment for herpes infections
- •History of facial keloids
- •Current diagnosis of adult acne or currently on treatment for adult acne
Outcomes
Primary Outcomes
VISIA-CR® images of each subject's face
Time Frame: 12 weeks
VISIA-CR® takes a series of standardized, reproducible digital facial images, inside of a controlled lighting environment. Subjects' front, left, and right views will be captured with their eyes gently closed using the following lighting parameters.
Secondary Outcomes
- Baseline Skin Questionnaire(12 weeks)
- End of Study Product Questionnaire"(12 weeks)
- Skin Update Questionnaire(12 weeks)