Health BehaviorNCT07640321
Oral Sialic Acid Product Beauty Efficacy Test
An observational study of Health Behavior, run by Wuhan CASOV Green Biotech Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Oral N-acetylneuraminic acid and OralACAI-PLUS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2023to 22 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese Asian women aged 40-65, with facial skin issues such as pigmentation spots, lack of elasticity, and wrinkles
Who may be able to join
- 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
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- ≤ 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Health Behavior
- Being tested
- Oral placebo, Oral N-acetylneuraminic acid, OralACAI-PLUS
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral placeboDietary supplement
Oral placebo once daily for 84 consecutive days
Oral N-acetylneuraminic acidDietary supplement
Oral N-acetylneuraminic acid, once daily, for 84 consecutive days
OralACAI-PLUSDietary supplement
Oral ACAI-PLUS, once a day, for 84 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Group A | placebo Receives: Dietary Supplement: Oral placebo | |
| Group B | N-acetylneuraminic acid Receives: Dietary Supplement: Oral N-acetylneuraminic acid | |
| Group C | ACAI-PLUS Receives: Dietary Supplement: OralACAI-PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day0、Day28、Day56、Day84
Secondary outcomes (8)
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)
Measured: Day0、Day28、Day56、Day84
Dermal echo parameters
Using Dermcup® high-frequency B-mode ultrasound scanning (25 MHz probe) to obtain dermal echo parameters
Measured: Day0、Day28、Day56、Day84
Color and clarity of spots
Dermatologists use Pantone color cards to score the color and clarity of spots
Measured: 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
Measured: Day0、Day28、Day56、Day84
Stratum corneum moisture index
Corneometer® CM825 capacitance measurement method to obtain Stratum corneum moisture index
Measured: Day0、Day28、Day56、Day84
Biomechanical properties of the skin
DTM310 Diastron® torque meter obtains information on skin biomechanical properties
Measured: Day0、Day28、Day56、Day84
Freckle removal effect
Siascope V® spectrophotometric intradermal analysis obtains information on freckle removal effects
Measured: 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.
Measured: Day28、Day56、Day84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start25 Sep 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan CASOV Green Biotech Co., Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- COSderma China Laboratory (Wuhan, China）
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640321
- Sponsor's protocol ID
- SECCR/2022-132-01
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07640321
- Acronym / sponsor ID
- SECCR/2022-132-01
- Conditions
- Health Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Wuhan CASOV Green Biotech Co., LtdUniversity, hospital or other
- Collaborators
- COSderma China Laboratory (Wuhan, China）
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Dietary Supplement: Oral placeboplacebo |
| Group B | – | Dietary Supplement: Oral N-acetylneuraminic acidN-acetylneuraminic acid |
| Group C | – | Dietary Supplement: OralACAI-PLUSACAI-PLUS |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Asian women aged 40-65, with facial skin issues such as pigmentation spots, lack of elasticity, and wrinkles
Key inclusion criteria (12 listed)
- Skin type origin: Asian in China
- Age: from 40 to 65 years old
- Gender: female
- Specific criteria:
- ≤ 6 according 10 points scale
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral placeboOral placebo once daily for 84 consecutive days | Dietary supplement | Group A |
| Oral N-acetylneuraminic acidOral N-acetylneuraminic acid, once daily, for 84 consecutive days | Dietary supplement | Group B |
| OralACAI-PLUSOral ACAI-PLUS, once a day, for 84 consecutive days | Dietary supplement | Group C |
Primary outcome
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)
8 secondary outcomes
Self-assessment by subjects
Time frame: Day0、Day28、Day56、Day84
Dermal echo parameters
Time frame: Day0、Day28、Day56、Day84
Color and clarity of spots
Time frame: Day0、Day28、Day56、Day84
Wrinkles, skin tone uniformity, and spots
Time frame: Day0、Day28、Day56、Day84
Stratum corneum moisture index
Time frame: Day0、Day28、Day56、Day84
Biomechanical properties of the skin
Time frame: Day0、Day28、Day56、Day84
Freckle removal effect
Time frame: Day0、Day28、Day56、Day84
Self-assessment of cosmetic quality and efficacy
Time frame: Day28、Day56、Day84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by Wuhan CASOV Green Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin clinical scores (time frame: Day0、Day28、Day56、Day84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.