Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Skin Health

• NCT number: NCT03771807
• Study type: Interventional
• Source: Pharmanex
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Completion date: June 20, 2020