Oral Sialic Acid Product Beauty Efficacy Test

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Dietary supplement: Oral placebo; Dietary supplement: Oral N-acetylneuraminic acid; Dietary supplement: OralACAI-PLUS

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • COSderma China Laboratory (Wuhan, China）

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Chinese Asian women aged 40-65, with facial skin issues such as pigmentation spots, lack of elasticity, and wrinkles

Description

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

  1. presenting with a lack of elasticity to the face, inclusion grade

     ≤ 6 according 10 points scale

  2. presenting with a lack of density to the face, inclusion grade ≤ 6 according 10 points scale
  3. presenting with wrinkles on crow's feet area, grade ≥ 2 according to Skin ageing atlas Vol.2 (p.41)
  4. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; placebo	Dietary supplement: Oral placebo; Oral placebo once daily for 84 consecutive days
Group B; N-acetylneuraminic acid	Dietary supplement: Oral N-acetylneuraminic acid; Oral N-acetylneuraminic acid, once daily, for 84 consecutive days
Group C; ACAI-PLUS	Dietary supplement: OralACAI-PLUS; Oral ACAI-PLUS, once a day, for 84 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin clinical scores	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-assessment by subjects	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	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	Dermatologists use Pantone color cards to score the color and clarity of spots	Day0、Day28、Day56、Day84
Wrinkles, skin tone uniformity, and spots	COSderma Photobench photography + Newtone software analysis to obtain information on wrinkles, skin tone uniformity, and spots	Day0、Day28、Day56、Day84
Stratum corneum moisture index	Corneometer® CM825 capacitance measurement method to obtain Stratum corneum moisture index	Day0、Day28、Day56、Day84
Biomechanical properties of the skin	DTM310 Diastron® torque meter obtains information on skin biomechanical properties	Day0、Day28、Day56、Day84
Freckle removal effect	Siascope V® spectrophotometric intradermal analysis obtains information on freckle removal effects	Day0、Day28、Day56、Day84
Self-assessment of cosmetic quality and efficacy	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

Collaborators and Investigators

• Sponsor: Wuhan CASOV Green Biotech Co., Ltd
• Collaborators: COSderma China Laboratory (Wuhan, China）

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Organic Chemicals; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Sialic Acids; Neuraminic Acids; Amino Sugars; N-Acetylneuraminic Acid
• Other Study ID Numbers: SECCR/2022-132-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No