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

Sponsor

Natals, Inc. dba Ritual (Industry)

Overall Status

Completed

CT.gov ID

NCT06083402

Collaborator

(none)

Enrollment

Location

Arms

3.8

Actual Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Aging	Dietary Supplement: HyaCera™ Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 weeksHealthy 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

Masking:

Double (Participant, 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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 12, 2023

Actual Primary Completion Date :

Oct 6, 2023

Actual Study Completion Date :

Oct 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Participants receive 1 HyaCera™ capsule orally once daily for 12 weeks	Dietary Supplement: HyaCera™ 1 Ritual HyaCera capsule once daily
Placebo Comparator: Placebo Participants receive 1 placebo capsule orally once daily for 12 weeks	Dietary Supplement: Placebo 1 placebo capsule once daily

Arm

Intervention/Treatment

Active Comparator: Active

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

Dietary Supplement: HyaCera™

1 Ritual HyaCera capsule once daily

Placebo Comparator: Placebo

Participants receive 1 placebo capsule orally once daily for 12 weeks

Dietary Supplement: Placebo

1 placebo capsule once daily

Outcome Measures

Primary Outcome Measures

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®
Skin Smoothness [at week 0, Week 4, Week 8, and Week 12]
Skin smoothness will be measured via Visioscan®
Skin Hydration [at week 0, Week 4, Week 8, and Week 12]
Skin surface hydration will be measured via Corneometer® 825

Secondary Outcome Measures

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®
Skin Scaliness [at week 0, Week 4, Week 8, and Week 12]
Skin scaliness will be measured via Visioscan®

Other Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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