NCT06083402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

August 16, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

skin agingskin wrinklesskin hydrationskin elasticityskin firmnessskin smoothnesscrow's feet wrinklesdietary supplementskin barrier function

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Skin Elasticity

    at week 0, Week 4, Week 8, and Week 12

  • Skin Barrier Function

    at week 0, Week 4, Week 8, and Week 12

  • Skin Scaliness

    at week 0, Week 4, Week 8, and Week 12

Other Outcomes (2)

  • Dermatologist grading of skin condition

    at week 0, Week 4, Week 8, and Week 12

  • Self-evaluation of perceived changes in skin condition

    at week 0, Week 4, Week 8, and Week 12

Study Arms (2)

Active

ACTIVE COMPARATOR

Participants receive 1 HyaCera™ capsule orally once daily for 12 weeks

Dietary Supplement: HyaCera™

Placebo

PLACEBO COMPARATOR

Participants receive 1 placebo capsule orally once daily for 12 weeks

Dietary Supplement: Placebo

Interventions

HyaCera™DIETARY_SUPPLEMENT

1 Ritual HyaCera capsule once daily

Active
PlaceboDIETARY_SUPPLEMENT

1 placebo capsule once daily

Placebo

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princeton Consumer Research

Raritan, New Jersey, 08869, United States

Location

Related Publications (1)

  • Grier-Welch AM, Vance AY, Alamdari N, Sharafi M. Efficacy of an Oral Skincare Supplement on Skin Aging: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2025 Dec;15(12):3689-3702. doi: 10.1007/s13555-025-01556-2. Epub 2025 Oct 10.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2023

First Posted

October 16, 2023

Study Start

June 12, 2023

Primary Completion

October 6, 2023

Study Completion

October 6, 2023

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations