Health Behavior
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTOral placebo
Oral placebo once daily for 84 consecutive days
DIETARY_SUPPLEMENTOral N-acetylneuraminic acid
Oral N-acetylneuraminic acid, once daily, for 84 consecutive days
DIETARY_SUPPLEMENTOralACAI-PLUS
Oral ACAI-PLUS, once a day, for 84 consecutive days
Sponsors
Wuhan CASOV Green Biotech Co., Ltd
COSderma China Laboratory (Wuhan, China）
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin clinical scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-assessment by subjects | 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) |
| Dermal echo parameters | Day0、Day28、Day56、Day84 | Using Dermcup® high-frequency B-mode ultrasound scanning (25 MHz probe) to obtain dermal echo parameters |
| Color and clarity of spots | Day0、Day28、Day56、Day84 | Dermatologists use Pantone color cards to score the color and clarity of spots |
| Wrinkles, skin tone uniformity, and spots | Day0、Day28、Day56、Day84 | COSderma Photobench photography + Newtone software analysis to obtain information on wrinkles, skin tone uniformity, and spots |
| Stratum corneum moisture index | Day0、Day28、Day56、Day84 | Corneometer® CM825 capacitance measurement method to obtain Stratum corneum moisture index |
| Biomechanical properties of the skin | Day0、Day28、Day56、Day84 | DTM310 Diastron® torque meter obtains information on skin biomechanical properties |
| Freckle removal effect | Day0、Day28、Day56、Day84 | Siascope V® spectrophotometric intradermal analysis obtains information on freckle removal effects |
| Self-assessment of cosmetic quality and efficacy | 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. |
Countries
China
Outcome results
None listed