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Completed

NCT Number: NCT06083402

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

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.

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Key information

Conditions

Skin Aging

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Consumer Research

Raritan, New Jersey, 08869, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HyaCera™

Dietary Supplement

1 Ritual HyaCera capsule once daily

Placebo

Dietary Supplement

1 placebo capsule once daily

Primary outcomes

  1. Crow's Feet Wrinkles

    Time frame: at week 0, Week 4, Week 8, and Week 12

    Degree of crow's feet wrinkling will be measured via Visioscan®

  2. Skin Smoothness

    Time frame: at week 0, Week 4, Week 8, and Week 12

    Skin smoothness will be measured via Visioscan®

  3. Skin Hydration

    Time frame: at week 0, Week 4, Week 8, and Week 12

    Skin surface hydration will be measured via Corneometer® 825

Secondary outcomes

  1. Skin Elasticity

    Time frame: at week 0, Week 4, Week 8, and Week 12

    Skin elasticity will be measured via Cutometer® MPA 580

  2. Skin Barrier Function

    Time frame: at week 0, Week 4, Week 8, and Week 12

    Skin barrier function (as transepidermal water loss) will be measured via Tewameter®

  3. Skin Scaliness

    Time frame: at week 0, Week 4, Week 8, and Week 12

    Skin scaliness will be measured via Visioscan®

Other outcomes

  1. Dermatologist grading of skin condition

    Time frame: 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)

  2. Self-evaluation of perceived changes in skin condition

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Natals, Inc. dba Ritual

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 16, 2023
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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