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Completed

NCT Number: NCT07640321

Oral Sialic Acid Product Beauty Efficacy Test

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

COSderma China Laboratory (Wuhan, China)

Wuhan, Hubei, 430071, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral placebo

Dietary Supplement

Oral placebo once daily for 84 consecutive days

Oral N-acetylneuraminic acid

Dietary Supplement

Oral N-acetylneuraminic acid, once daily, for 84 consecutive days

OralACAI-PLUS

Dietary Supplement

Oral ACAI-PLUS, once a day, for 84 consecutive days

Primary outcomes

  1. Skin clinical scores

    Time frame: 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)

Secondary outcomes

  1. Self-assessment by subjects

    Time frame: 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)

  2. Dermal echo parameters

    Time frame: Day0、Day28、Day56、Day84

    Using Dermcup® high-frequency B-mode ultrasound scanning (25 MHz probe) to obtain dermal echo parameters

  3. Color and clarity of spots

    Time frame: Day0、Day28、Day56、Day84

    Dermatologists use Pantone color cards to score the color and clarity of spots

  4. Wrinkles, skin tone uniformity, and spots

    Time frame: Day0、Day28、Day56、Day84

    COSderma Photobench photography + Newtone software analysis to obtain information on wrinkles, skin tone uniformity, and spots

  5. Stratum corneum moisture index

    Time frame: Day0、Day28、Day56、Day84

    Corneometer® CM825 capacitance measurement method to obtain Stratum corneum moisture index

  6. Biomechanical properties of the skin

    Time frame: Day0、Day28、Day56、Day84

    DTM310 Diastron® torque meter obtains information on skin biomechanical properties

  7. Freckle removal effect

    Time frame: Day0、Day28、Day56、Day84

    Siascope V® spectrophotometric intradermal analysis obtains information on freckle removal effects

  8. Self-assessment of cosmetic quality and efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wuhan CASOV Green Biotech Co., Ltd

Other

Collaborators

  • COSderma China Laboratory (Wuhan, China)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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