Skin Aging
Conditions
Keywords
skin aging, skin wrinkles, skin hydration, skin elasticity, skin firmness, skin smoothness, crow's feet wrinkles, dietary supplement, skin barrier function
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTHyaCera™
1 Ritual HyaCera capsule once daily
DIETARY_SUPPLEMENTPlacebo
1 placebo capsule once daily
Sponsors
Natals, Inc. dba Ritual
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by the sponsor and marked with unidentifiable ID numbers before being sent to study site.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Hydration | at week 0, Week 4, Week 8, and Week 12 | Skin surface hydration will be measured via Corneometer® 825 |
| Skin Smoothness | at week 0, Week 4, Week 8, and Week 12 | Skin smoothness will be measured via Visioscan® |
| Crow's Feet Wrinkles | at week 0, Week 4, Week 8, and Week 12 | Degree of crow's feet wrinkling will be measured via Visioscan® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Scaliness | at week 0, Week 4, Week 8, and Week 12 | Skin scaliness will be measured via Visioscan® |
| Skin Elasticity | at week 0, Week 4, Week 8, and Week 12 | Skin elasticity will be measured via Cutometer® MPA 580 |
| Skin Barrier Function | at week 0, Week 4, Week 8, and Week 12 | Skin barrier function (as transepidermal water loss) will be measured via Tewameter® |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dermatologist grading of skin condition | at week 0, Week 4, Week 8, and Week 12 | Visual and tactile dermatologist evaluation of skin condition (fine lines in the crow's feet area, wrinkles in the crow's feet area, skin dryness, skin radiance, and skin smoothness) based on 10-point grading scale (with 0 being no signs of aging and 9 being the most severe) |
| Self-evaluation of perceived changes in skin condition | at week 0, Week 4, Week 8, and Week 12 | Self-evaluation of changes in skin condition and signs of skin aging (i.e. fine lines & wrinkles, skin texture, skin smoothness, skin plumpness, skin glow/radiance, skin hydration, skin elasticity, skin redness, skin itchiness) using a 5-point Likert scale (options: much worse, somewhat worse, stayed the same, somewhat better, much better) |
Countries
United States
Outcome results
None listed