Skin Health Clinical Trial
Official title:
A Single-center, Placebo Controlled Study to Investigate the Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
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:
- Review medical history
- Review concomitant medications
- Measure height, weight, BMI, heart rate, blood pressure
- Review inclusion/exclusion criteria
If the subject meets inclusion/exclusion criteria they will complete the following study
assessments.
- Skin examination
- Investigator facial clinical grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Digital photo of face
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:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
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:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
- Dispense 2 months of assigned study product
- Dispense skin cleansing machine and provide instruction on daily use to the right half
of their face only
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:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
- Return unused study product and dispense enough assigned study product to make it
through next study visit
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:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
- Return unused study product and dispense enough assigned study product to make it
through next study visit
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:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
- Collect skin cleansing machine
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
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:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
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