A 56-Day Exploratory Study of NatureU® Mind Care BeautyU Caps on Skin Aging Parameters (NUAA)

A 56-Day Single-Arm Exploratory Study of NatureU® Mind Care BeautyU Caps on Crow's-Feet Wrinkle Count, Skin Hydration, and Related Skin-Aging Parameters in Adult Women

This was a 56-day, single-center, open-label, single-arm exploratory study evaluating within-participant changes in skin-aging parameters after daily oral intake of NatureU® Mind Care BeautyU Caps in adult women. Participants took one capsule daily for 56 days. The primary outcome was change from baseline in crow's-feet wrinkle count at Day 56 assessed by PRIMOS CR imaging. The secondary outcome was change from baseline in stratum corneum hydration at Day 56 assessed by Corneometer CM 825. Additional exploratory outcomes included other wrinkle topography parameters, skin elasticity, radiance, pigmentation, pore-related parameters, dermal thickness and density, and participant-reported skin appearance outcomes.

Study Overview

Status

Completed

Conditions

Detailed Description

The study was designed as an exploratory, signal-generating human evaluation of an oral nutricosmetic supplement. Adult female participants received NatureU® Mind Care BeautyU Caps once daily for 56 days and underwent skin assessments at baseline, Day 28, and Day 56. Instrumental assessments included PRIMOS CR imaging for wrinkle-related parameters and Corneometer CM 825 measurement for stratum corneum hydration. Additional skin-aging parameters were assessed using validated or commonly used skin analysis instruments according to the study protocol. The study was single-arm and open-label, with no placebo or parallel control group. Analyses were based on participants who completed the study assessments.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • CTI AiPu Medical Laboratory (Shanghai) Co., Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult woman aged 36 to 56 years, inclusive.
  • Healthy participant as judged by the investigator.
  • Cheek skin hydration below 60 C.U.
  • Visible crow's-feet wrinkles.
  • Facial laxity or reduced facial radiance.
  • At least one visible facial spot meeting the prespecified size and ITA value criteria.
  • Willing to take the study product once daily for 56 consecutive days.
  • Willing to complete scheduled skin assessments at baseline, Day 28, and Day 56.
  • Willing to maintain regular lifestyle habits during the study period.
  • Willing to avoid confounding skincare products, cosmetic procedures, medications, and health products during the study period.
  • Provided written informed consent before any study-related procedure.

Exclusion Criteria:

  • Skin condition that could interfere with study assessments.
  • Highly allergic constitution.
  • Known allergy or intolerance to any ingredient of the study product.
  • Pregnant or lactating.
  • Planned pregnancy during the study period.
  • Severe systemic illness.
  • Serious psychiatric disorder.
  • Serious endocrine disorder.
  • Recent participation in another clinical study.
  • Recent use of products or procedures that could influence skin outcomes.
  • Use of other oral or topical products that could interfere with skin-aging assessments during the study period.
  • Recent cosmetic dermatology procedures or treatments that could affect the target assessment areas.
  • Inability to comply with study procedures.
  • Any condition judged by the investigator to make participation inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NatureU® Mind Care BeautyU Caps
Participants received NatureU® Mind Care BeautyU Caps, one capsule orally once daily for 56 days.
An oral nutricosmetic supplement containing PQQ, quercetin, ergothioneine, cranberry polyphenols, and related formulation components. Participants took one capsule daily for 56 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Crow's-Feet Wrinkle Count at Day 56
Time Frame: Baseline and Day 56
Crow's-feet wrinkle count was assessed using PRIMOS CR imaging. The primary endpoint was the within-participant change from baseline to Day 56.
Baseline and Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Stratum Corneum Hydration at Day 56
Time Frame: Baseline and Day 56
Skin hydration was assessed using Corneometer CM 825. The secondary endpoint was the within-participant change from baseline to Day 56.
Baseline and Day 56

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Additional Wrinkle Topography Parameters at Day 28 and Day 56
Time Frame: Day 28, Day 56
Wrinkle Topography Parameters
Day 28, Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2025

Primary Completion (Actual)

March 8, 2025

Study Completion (Actual)

March 8, 2025

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • A225000034310100101C (Other Identifier: CTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy protection and ethical considerations.

Study Data/Documents

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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