Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dermatology Consulting Services, High Point NC | OTHER |
Not provided
Not provided
Not provided
Not provided
Consumption of dietary supplements has been found to modulate skin health. Individual ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin health. Collagen peptides have been shown to clinically improve skin texture, decrease area of skin ultraviolet damage, increase skin hydration, and improve visible skin results such as hydration, elasticity, wrinkles and roughness. Lutein has been demonstrated to increase skin radiance, protect skin from ultraviolet light, and increase skin hydration. Ceramides derived from wheat have been shown to improve skin texture, increase skin hydration and improve visible skin attributes such as hydration, elasticity, and wrinkles. This study will have subjects consuming a nutritional supplement or placebo daily for 90 days to see if there is an effect on skin health. This study will also have the subjects using a facial cleansing device, which has been shown to improve skin health, on half of their face to determine if there is a synergistic effect between dietary supplement and cleansing device. It is believed, this mixture of collagen peptides, lutein and ceramides has not been studied and the study sponsor hypothesize that this blend of ingredients will have a positive impact on skin health.
Visit 1 Screening (day -30 to -1): Subjects will be given a copy of the informed consent document. They will be given ample time to read and formulate questions prior to reviewing the document with study staff. The consent form will be reviewed with the subject and questions will be answered. The subject will provide written consent prior to starting any study related assessments. The study staff will collect the following information during this visit:
If the subject meets inclusion/exclusion criteria they will complete the following study assessments.
Visit 2 Baseline (day 0): Subjects will return to the research site for baseline visit approximately 30 days after their screening visit. Subjects will undergo assessments to determine that they continue to meet inclusion/exclusion criteria. Subjects who are eligible will be enrolled into the study and assigned a randomization number and study product. The following assessments will be completed during this visit:
Visit 3 Baseline + 24hrs (day 1): Subjects will return to the research site approximately 24hrs after their baseline visit. The following assessments will be completed during this visit:
Visit 4 (day 30 +5 days): Subjects will return at approximately 30 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
Visit 5 (day 60 +5 days): Subjects will return at approximately 60 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
Visit 6 (day 90 +5 days): Subjects will return at approximately 90 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
Visit 7 (24 hours after visit 6): Subjects will return to the research site approximately 24hrs after visit 6. The following assessments will be completed during this visit:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo & facial cleansing | Placebo Comparator | Maltodextrin and food coloring Subjects will clean the right side of their face with a cosmetic instrument daily |
|
| Beauty From Within & facial cleansing | Active Comparator | Study Product contains collagen hydrolysate, ceramide wheat extract oil and lutein Subjects will clean the right side of their face with a cosmetic instrument daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beauty From Within | Dietary Supplement | one scoop of product mixed in 8-16 ounces of water consumed once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Health (lines) | Change from baseline in investigator and subject facial grading of lines (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data | baseline, day 30, day 60, and day 90 |
| Skin Health (firmness) | Change from baseline in investigator and subject facial grading of firmness (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data | baseline, day 30, day 60, and day 90 |
| Skin Health (radiance) | Change from baseline in investigator and subject facial grading of radiance (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data | baseline, day 30, day 60, and day 90 |
| Skin Health (texture) | Change from baseline in investigator and subject facial grading of texture (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data | baseline, day 30, day 60, and day 90 |
| Skin Health (overall) | Change from baseline in investigator and subject facial grading overall (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data | baseline, day 30, day 60, and day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular protection of the skin as determined by dermospectrophotometer of UV irradiated site | Change from baseline in dermospectrophotometer at day 91 using Student T-test | baseline, and day 91 |
| Skin elasticity of face determined by cutometer |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zoe D Draelos, MD | Dermatology Consulting Services, High Point NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bizot, V., E. Cestone, A. Michelotti and V. Nobile. Improving skin hydration and age-related symptoms by oral administration of wheat glucosylceramides and digalactosyl diglycerides: a human clinical study. Cosmetics 4(37): 2017 | ||
| 27785083 | Background | Juturu V, Bowman JP, Deshpande J. Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial. Clin Cosmet Investig Dermatol. 2016 Oct 7;9:325-332. doi: 10.2147/CCID.S115519. eCollection 2016. | |
| 15538079 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | one scoop of product mixed in 8-16 ounces of water consumed once daily |
|
| Facial cleansing | Other | All subjects will use a cosmetic instrument to clean on one half of their face daily |
|
Change from baseline in skin elasticity at days 30, 60, and 90 using Student T-test
| baseline, day 30, day 60, and day 90 |
| Ramen skin carotenoids score determined by carotenoid scan of left hand | Change from baseline in skin carotenoids at days 30, 60, and 90 using Student T-test | baseline, day 30, day 60, and day 90 |
| Benefits of facial cleansing in concurrence with dietary supplement | Determine if facial cleansing improves outcomes over dietary supplement use alone as determined by investigator assessment using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe in lines, firmness, radiance, texture, and overall of both sides of the subjects face | baseline, day 30, day 60, and day 90 |
| Background |
| Morganti P, Fabrizi G, Bruno C. Protective effects of oral antioxidants on skin and eye function. Skinmed. 2004 Nov-Dec;3(6):310-6. doi: 10.1111/j.1540-9740.2004.02420.x. |
| 17446716 | Background | Palombo P, Fabrizi G, Ruocco V, Ruocco E, Fluhr J, Roberts R, Morganti P. Beneficial long-term effects of combined oral/topical antioxidant treatment with the carotenoids lutein and zeaxanthin on human skin: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2007;20(4):199-210. doi: 10.1159/000101807. Epub 2007 Apr 19. |
| 24401291 | Background | Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24. |
| 23949208 | Background | Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14. |