Clinical trial NCT06083402: Efficacy of a Dietary Supplement on Parameters of Skin Aging in Men and Women
Official title: Evaluating the Efficacy of a Dietary Supplement on Parameters of Skin Aging: a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Keywords: skin aging
skin wrinkles
skin hydration
skin elasticity
skin firmness
skin smoothness
crow's feet wrinkles
dietary supplement
skin barrier function
Lead sponsor: Natals, Inc. dba Ritual
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 63
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Crow's Feet Wrinkles
timeFrame: at week 0, Week 4, Week 8, and Week 12
measure: Skin Smoothness
timeFrame: at week 0, Week 4, Week 8, and Week 12
measure: Skin Hydration
timeFrame: at week 0, Week 4, Week 8, and Week 12
Secondary outcomes:
measure: Skin Elasticity
timeFrame: at week 0, Week 4, Week 8, and Week 12
measure: Skin Barrier Function
timeFrame: at week 0, Week 4, Week 8, and Week 12
measure: Skin Scaliness
timeFrame: at week 0, Week 4, Week 8, and Week 12
Other outcomes:
measure: Dermatologist grading of skin condition
timeFrame: at week 0, Week 4, Week 8, and Week 12
measure: Self-evaluation of perceived changes in skin condition
timeFrame: at week 0, Week 4, Week 8, and Week 12
Locations:
city: Raritan
country: United States
facility: Princeton Consumer Research
state: New Jersey
Study officials:
References: