A 56-Day Exploratory Study of NatureU® Mind Care BeautyU Caps on Skin Aging Parameters (NUAA)
14. september 2026 opdateret af: OmniSolutions Laboratory Holdings Limited
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
33
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200040
- CTI AiPu Medical Laboratory (Shanghai) Co., Ltd
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Crow's-Feet Wrinkle Count at Day 56
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Stratum Corneum Hydration at Day 56
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Additional Wrinkle Topography Parameters at Day 28 and Day 56
Tidsramme: Day 28, Day 56
|
Wrinkle Topography Parameters
|
Day 28, Day 56
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. januar 2025
Primær færdiggørelse (Faktiske)
8. marts 2025
Studieafslutning (Faktiske)
8. marts 2025
Datoer for studieregistrering
Først indsendt
30. april 2026
Først indsendt, der opfyldte QC-kriterier
30. april 2026
Først opslået (Faktiske)
6. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- A225000034310100101C (Anden identifikator: CTI)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be shared due to privacy protection and ethical considerations.
Studiedata/dokumenter
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .