Efficacy of a Dietary Supplement on Parameters of Skin Aging in Men and Women

Study Overview
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Brief Summary
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As the body ages, the skin experiences natural changes in structure and composition. These changes may manifest visibly as increased skin dryness, wrinkling, and a loss of firmness/elasticity. In this double-blind, randomized, placebo-controlled trial, the investigators will recruit healthy men and women with mild to moderate signs of skin aging and randomly assign them to either receive a HyaCera™ or placebo for 12 weeks. The investigators will perform a series of objective and subjective measurements to assess changes in skin condition. The investigators hypothesize that consumption of HyaCera™ leads to improvements in the general condition of the skin including skin hydration, crow's feet wrinkling, and other skin aging parameters.

Official Title
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Evaluating the Efficacy of a Dietary Supplement on Parameters of Skin Aging: a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study

Conditions
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Skin Aging

Intervention / Treatment
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* Dietary Supplement: HyaCera™
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female volunteers, 25 - 70 years old with mild to moderate fine lines and wrinkles All ethnicities and skin types Willing to maintain current skincare regimen on face, arms, and legs and withhold all facial and body treatments throughout the course of the study Exclusion Criteria: Self-reported pregnant or breastfeeding or planning to become pregnant during the course of the study Any conditions on the face, arms and legs that would interfere with evaluations Under treatment for any known health issues/medical conditions including chronic health conditions and skin diseases/conditions

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy men and women with mild to moderate signs of skin aging will be randomly assigned to either receive a Ritual HyaCera or placebo for 12 weeks
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Participants receive 1 HyaCera™ capsule orally once daily for 12 weeks | Dietary Supplement: HyaCera™<br>* 1 Ritual HyaCera capsule once daily<br>|
| Placebo Comparator: Placebo<br>Participants receive 1 placebo capsule orally once daily for 12 weeks | Dietary Supplement: Placebo<br>* 1 placebo capsule once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crow's Feet Wrinkles | Degree of crow's feet wrinkling will be measured via Visioscan® | at week 0, Week 4, Week 8, and Week 12 | 
| Skin Smoothness | Skin smoothness will be measured via Visioscan® | at week 0, Week 4, Week 8, and Week 12 | 
| Skin Hydration | Skin surface hydration will be measured via Corneometer® 825 | at week 0, Week 4, Week 8, and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Elasticity | Skin elasticity will be measured via Cutometer® MPA 580 | at week 0, Week 4, Week 8, and Week 12 | 
| Skin Barrier Function | Skin barrier function (as transepidermal water loss) will be measured via Tewameter® | at week 0, Week 4, Week 8, and Week 12 | 
| Skin Scaliness | Skin scaliness will be measured via Visioscan® | at week 0, Week 4, Week 8, and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin aging, skin wrinkles, skin hydration, skin elasticity, skin firmness, skin smoothness, crow's feet wrinkles, dietary supplement, skin barrier function