- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07640321
Oral Sialic Acid Product Beauty Efficacy Test
8. juni 2026 oppdatert av: Wuhan CASOV Green Biotech Co., Ltd
Assessment and Comparison on 3 Groups of 25 Human Beings of the Effect on the Cutaneous State, the Dermis Echogenicity, the Moisturizing Effect, the Depigmenting Effect, the Effect on the Biomechanical Properties and the Effect on Wrinkles, Color and Homogeneity and Pigmentary Spots of Cosmetic Product N°1 vs Cosmetic Product N°2 vs Placebo After Oral Intake in Conditions of Normal Use During 28, 56 and 84 Days: Self-assessment of the Cosmetic Qualities and Efficacy
Evaluate and compare the effects on female facial skin of oral placebo (Product A), N-acetylneuraminic acid (Product B), and ACAI-PLUS (Product C) after 28, 56, and 84 days under normal usage conditions.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
83
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430071
- COSderma China Laboratory (Wuhan, China)
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Chinese Asian women aged 40-65, with facial skin issues such as pigmentation spots, lack of elasticity, and wrinkles
Beskrivelse
Inclusion Criteria:
- Skin type origin: Asian in China
- Age: from 40 to 65 years old
- Gender: female
Specific criteria:
• All skin type on the face Dry, dry combination, normal
presenting with a lack of elasticity to the face, inclusion grade
≤ 6 according 10 points scale
- presenting with a lack of density to the face, inclusion grade ≤ 6 according 10 points scale
- presenting with wrinkles on crow's feet area, grade ≥ 2 according to Skin ageing atlas Vol.2 (p.41)
- presenting with pigmentary spots with at least one with diameter ≥ 3mm
- Usual or occasional user of food supplements
- Able to give her informed consent
Exclusion Criteria:
The non-inclusion general criteria were the following ones:
- allergies or reactivity to cosmetic products,
- for the subjects undergoing hormonal treatment; change of treatment within 3 months preceding the inclusion visit,
- expectation of change in the current hormonal treatment during the study,
- anti-allergic, antibiotic, anti-inflammatory, dermatological treatment or corticosteroid therapy within 2 weeks before the inclusion visit,
- having a chronic pathology,
- performing or prevision to perform another test during the study or during the exclusion period,
- employee of the COSderma laboratory,
- pregnant or breast-feeding woman,
- woman not taking precaution to prevent pregnancy.
The non-inclusion specific criteria were the following ones:
- application of care products to the face within 48 hours preceding the inclusion visit,
- application of make-up products to the face the day of the inclusion visit,
- face wash with any other means than clear water (no soap or cleanser) on the day of the inclusion visit,
- application of self-tanning products to the face within 4 weeks preceding the inclusion visit,
- Oral intake of food supplement within 1 month preceding the inclusion visit,
- cutaneous marks on the face which could interfere with the skin's clinical signs assessment (pigmentation issues, scar tissues, over-developed hairiness, too many ephelides and naevi, sunburns...),
- solar exposition (natural sun or UVA or heliotherapy treatment) within 4 weeks preceding the inclusion visit and expectation of solar exposition (natural or UVA) during the study,
- Vitamin A acid treatment or its derivatives within 3 months preceding the pre-inclusion visit,
- Retinoid based oral treatment within 6 months before the pre-inclusion visit, or local treatment within 2 months prior to this visit,
- Carotene based treatment within 4 weeks preceding the inclusion visit,
- expectation or having undergone aesthetic or dermatological surgery on the face.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Group A
placebo
|
Oral placebo once daily for 84 consecutive days
|
|
Group B
N-acetylneuraminic acid
|
Oral N-acetylneuraminic acid, once daily, for 84 consecutive days
|
|
Group C
ACAI-PLUS
|
Oral ACAI-PLUS, once a day, for 84 consecutive days
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skin clinical scores
Tidsramme: Day0、Day28、Day56、Day84
|
Dermatologists use a 10-point scale (0-9) and Volume 2 of the Atlas of Skin Aging for visual/tactile assessment.
(includes elasticity, firmness, crow's feet, under-eye wrinkles, facial sagging, skin tone radiance, moisturization)
|
Day0、Day28、Day56、Day84
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-assessment by subjects
Tidsramme: Day0、Day28、Day56、Day84
|
Subjects self-rated using a 10-point scale (0-9).
(includes skin beauty, visibility of wrinkles, skin tone evenness, radiance, firmness)
|
Day0、Day28、Day56、Day84
|
|
Dermal echo parameters
Tidsramme: Day0、Day28、Day56、Day84
|
Using Dermcup® high-frequency B-mode ultrasound scanning (25 MHz probe) to obtain dermal echo parameters
|
Day0、Day28、Day56、Day84
|
|
Color and clarity of spots
Tidsramme: Day0、Day28、Day56、Day84
|
Dermatologists use Pantone color cards to score the color and clarity of spots
|
Day0、Day28、Day56、Day84
|
|
Wrinkles, skin tone uniformity, and spots
Tidsramme: Day0、Day28、Day56、Day84
|
COSderma Photobench photography + Newtone software analysis to obtain information on wrinkles, skin tone uniformity, and spots
|
Day0、Day28、Day56、Day84
|
|
Stratum corneum moisture index
Tidsramme: Day0、Day28、Day56、Day84
|
Corneometer® CM825 capacitance measurement method to obtain Stratum corneum moisture index
|
Day0、Day28、Day56、Day84
|
|
Biomechanical properties of the skin
Tidsramme: Day0、Day28、Day56、Day84
|
DTM310 Diastron® torque meter obtains information on skin biomechanical properties
|
Day0、Day28、Day56、Day84
|
|
Freckle removal effect
Tidsramme: Day0、Day28、Day56、Day84
|
Siascope V® spectrophotometric intradermal analysis obtains information on freckle removal effects
|
Day0、Day28、Day56、Day84
|
|
Self-assessment of cosmetic quality and efficacy
Tidsramme: Day28、Day56、Day84
|
By distributing 12 questionnaires to the subjects, self-assessment information on the quality and effectiveness of cosmetics was obtained.
A four-point Likert scale was used (Agree, Somewhat Agree, Somewhat Disagree, Disagree), and the questionnaire content included: 1. Skin feels better; 2. Skin becomes fairer; 3. Pigmentation on the skin lightens or decreases; 4. Skin becomes radiant; 5. Skin becomes more elastic; 6. Skin is firmer than before; 7. Skin wrinkles and fine lines improve; 8. Skin becomes moisturized/hydrated; 9. Skin's oil-water balance is better; 10.
Skin looks rejuvenated, full of energy; 11.
Sleep improves after consumption; 12. Memory improves after consumption.
|
Day28、Day56、Day84
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. september 2023
Primær fullføring (Faktiske)
22. desember 2023
Studiet fullført (Faktiske)
22. desember 2023
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SECCR/2022-132-01
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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