A randomized, double-blind, placebo-controlled study to investigate the effects of OmniActive Lutemax 2020® oil suspension on skin health attributes
- Conditions
- Skin healthSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN15646478
- Lead Sponsor
- OmniActive Health Technologies Inc
- Brief Summary
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27785083
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1. Healthy, pre-menopausal females aged 18 to 45 years
2. Healthy males aged 18-45 years
3. Subjects with mild to moderate dry skin (to be determined by the Investigator).
4. Fitzpatrick Skin Type II –IV scale
5. Non-smokers
6. A body mass index (BMI) of 20 to 34 kg/m2
7. Normal values, based on the opinion of investigator, for the following assays: clinical chemistry, hematology, and urinalysis
8. Willing to avoid lutein/zeaxanthin rich foods and follow the dietary restriction list provided by the PI during the study and for 10 days prior to enrollment
9. Subjects are willing to avoid prolonged exposure to UV radiation and sun bath for the duration of the study
10. Willingness to complete all clinic visits and to complete all diaries/records associated with the study
11. Willingness to avoid cosmetics (excluding sunscreen) and cosmetic procedures (i.e., chemical peels, microdermabrasion, laser treatment) that may affect the skin on the forearms and face.
12.Willingness to use only the provided body wash and body cream for the entire 12-week study duration and to follow specific instructions related to their use on study visit days. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid
13. Able to provide informed consent
14. Willingness not to apply regularly used make-up during each study visit
1. Subjects with moderate or severe acne.
2. Subjects who have participated in a clinical study in which they used Retin-A or a retinoid, alpha-hydroxy acids, salicylic acid or vitamin C for 3 months prior to enrollment.
3. Subjects currently using any topical medication on the face. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
4. History of, or current disease or condition of the skin that the investigator deems inappropriate for study participation (eg, atopic skin, acne vulgaris, facial scars, psoriasis, eczema, other scaly inflammatory diseases).
5. History of, or current diagnosis of uncontrolled chronic conditions eg liver, kidney, pulmonary, gastrointestinal, cardiovascular, pancreatic and/or immune diseases[1] (3 months on stable pharmacological treatment is acceptable).
6. History of, or current diagnosis of, cancer[1].
7. Diagnosed with hyperthyroidism or hypothyroidism[1].
8. Positive narcotics (urinalysis) or alcohol screen (breathalyzer).
9. Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 months from baseline or plan to have a treatment during the study.
10. Subjects using an alpha-hydroxy acid containing products within 3 months of enrollment. Continued use of current facial moisturizers and cleansers will be acceptable, but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
11. Subjects currently using a salicylic acid containing product on the face (including astringents and toners) 3 months prior to enrollment. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
12.Subjects currently using or have used products containing retinol or retinoid on the face (including moisturizers) 3 months prior to enrollment. Continued use of current facial moisturizers and cleansers will be acceptable, but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
13. Subjects currently under a physician’s care for a skin problem.
14. Taking any medication that could affect skin (eg, Tetracycline).
15. Recent sunburn or having peeling due to sunburn within 2 weeks of enrollment.
16. Taking vacation involving photo exposure (beaches or skiing) during the study.
17. Subjects have used tretinoin, adapalene, tazarotene or other topical retinoid medications for the treatment of facial skin aging 3 months prior to enrollment and during the study.
18. Subjects have used or plan to use systemic corticosteroids within 30 days of enrollment or during the study.
19. Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin (eg, antioxidants, anti-aging retinoids, antibiotics, corticosteroids) within one month of enrollment.
20. Subjects have a history of severe alcohol consumption or drug abuse in the past year (obtained through Medical History).
21. Subjects are participating in another interventional study.
22. Positive pregnancy test in women of child-bearing potential.
23. Pregnant or breast-feeding or planning on becoming pregnant.
24. Women of child-bearing potential not us
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Skin color<br>2. Skin tone<br>3. Photoprotective activity<br>4. Hydration<br>5. TEWL <br>6. Subjective assessments for skin health
- Secondary Outcome Measures
Name Time Method Blood analysis such as lutein and zeaxanthin isomers