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

Skin Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06083402
• Other study ID #: HyaCera2023
• Status: Completed
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: October 6, 2023

Study information

• Verified date: October 2023
• Source: Natals, Inc. dba Ritual
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Aging

Intervention

Dietary Supplement:
• HyaCera™
1 Ritual HyaCera capsule once daily
• Placebo
1 placebo capsule once daily

Locations

Country	Name	City	State
United States	Princeton Consumer Research	Raritan	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Natals, Inc. dba Ritual

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dermatologist grading of skin condition	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)	at week 0, Week 4, Week 8, and Week 12
Other	Self-evaluation of perceived changes in skin condition	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)	at week 0, Week 4, Week 8, and Week 12
Primary	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
Primary	Skin Smoothness	Skin smoothness will be measured via Visioscan®	at week 0, Week 4, Week 8, and Week 12
Primary	Skin Hydration	Skin surface hydration will be measured via Corneometer® 825	at week 0, Week 4, Week 8, and Week 12
Secondary	Skin Elasticity	Skin elasticity will be measured via Cutometer® MPA 580	at week 0, Week 4, Week 8, and Week 12
Secondary	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
Secondary	Skin Scaliness	Skin scaliness will be measured via Visioscan®	at week 0, Week 4, Week 8, and Week 12