Nutritional Supplement Efficacy on Cellular Protection and Skin Health in Generally Healthy Adults

Skin Health Clinical Trial

Official title: Nutritional Supplement Efficacy on Cellular Protection and Skin Health in Generally Healthy Adults

Status Completed

Clinical Trial Summary

Healthy skin has been equated with a healthy diet leading to the "inside out" approach to skin health. Since the skin is the barrier to the external world, healthy skin should lead to overall better health. Conversely, the skin derives its nutrition from the internal body requiring the consumption of nutritional supplements for optimal health. This research attempts to examine skin attributes and improved appearance achieved after consumption of a state-of-the-art dietary supplement.

Clinical Trial Description

Subjects will present to the research center and complete an informed consent. They will undergo assessment for inclusion/exclusion criteria, skin examination, BMI calculation, and a brief medical history. Subjects that are found to be appropriate for study entry will undergo an investigator and subject facial evaluation. In addition, they will undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. Facial photography will also be performed. A target site on the right or left sun protected buttock will be selected and will receive 1, 2, and 3 MED of solar simulated radiation.

Subjects will return to the research center 24 hours after irradiation for photography and erythema scaledermospectrophotometer measurement of the irradiated sites and biopsy of the 2

• 3 MED sites. The MED biopsy site will be consistent for each subject, but will be chosen based on the amount of achieved erythema. A 2mm punch biopsy will be taken of the irradiated site and another adjacent nonirradiated site for a total of 2 skin biopsies that will be closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be processed and shipped as instructed by the sponsor to a laboratory for epigenetic analysis. All subjects will be dispensed the supplement in a white bottle with a research center label along with a compliance diary. Subjects will return in 2 weeks just for suture removal.

At week 4, subjects will undergo an investigator and subject facial evaluation. In addition, they will undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. Subjects will be redispensed study supplements.

Subjects will return to the research facility at week 8 and undergo noninvasive measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a biophotonic scanner. A target site on the right or left sun protected buttock will be selected and will receive 1, 2, and 3 MED of solar simulated radiation. All supplement bottles and unused product will be collected. Subjects will return to the research center 24 hours after irradiation for photography and erythema scale dermospectrophotometer measurement of the irradiated sites and biopsy of the 2-3 MED sites. The biopsy site will be the same MEDs as the original biopsy site at baseline. A 2mm punch biopsy will be taken of the irradiated site and another adjacent nonirradiated site for a total of 2 skin biopsies that will be closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be processed and shipped as instructed by the sponsor to a laboratory for epigenetic analysis. All supplement bottles and unused product will be collected. All bottles and unused product will be returned to the sponsor.

Subjects will return to the research center at week 10 for suture removal only. ;

Related Conditions & MeSH terms

• Skin Health

• NCT number: NCT02525224
• Study type: Interventional
• Source: Pharmanex
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Completion date: September 2015