- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07640321
Oral Sialic Acid Product Beauty Efficacy Test
8 juni 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
83
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Hubei
-
Wuhan, Hubei, Kina, 430071
- COSderma China Laboratory (Wuhan, China)
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Chinese Asian women aged 40-65, with facial skin issues such as pigmentation spots, lack of elasticity, and wrinkles
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Skin clinical scores
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-assessment by subjects
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Day0、Day28、Day56、Day84
|
Corneometer® CM825 capacitance measurement method to obtain Stratum corneum moisture index
|
Day0、Day28、Day56、Day84
|
|
Biomechanical properties of the skin
Tidsram: Day0、Day28、Day56、Day84
|
DTM310 Diastron® torque meter obtains information on skin biomechanical properties
|
Day0、Day28、Day56、Day84
|
|
Freckle removal effect
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
25 september 2023
Primärt slutförande (Faktisk)
22 december 2023
Avslutad studie (Faktisk)
22 december 2023
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
10 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SECCR/2022-132-01
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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