Cosmetic composition for external use for correction of signs of skin aging and method for its application

Abstract

FIELD: cosmetology.SUBSTANCE: group of inventions relates to the correction of signs of skin aging. A cosmetic composition for external use to correct signs of skin aging contains an extract of the root of Astragalusmembranaceus in an amount of 5–7 wt.%, N-acetyl-L-cysteine in an amount of 2–4 wt.% and L-carnosine in an amount of 2–3 wt.%, while the total content of active components is 8-14 wt.%. A method for correcting signs of skin aging is also disclosed.EFFECT: providing anti-aging effect.10 cl, 3 dwg, 1 tbl, 4 ex

Description

[0001] Field of technology to which the invention relates

[0002] The invention relates to cosmetology, in particular to cosmetic compositions for skin care that have an anti-aging effect, and can be used to correct signs of skin aging, such as wrinkles, decreased elasticity, dull complexion and hyperpigmentation.

[0003] Technology Level

[0004] Cosmetics compositions containing various active ingredients for the care of aging skin are known. For example, patent CA 2630161 C discloses a skin care composition containing a mixture of N-acetylcysteine ​​and L-carnosine. This patent can be considered the closest analogue of the present invention. Patent application JP 2011246354 A describes a topical agent containing an extract of plants of the genus Astragalus as an agent that breaks down advanced glycation end products. Patent EP 2094286 B1 discloses cosmetic skin care compositions that can include Astragalus Glycyphyllos as an active ingredient.Application WO 2013096725 A1 describes an aqueous solution of astragalus seed extract prepared by a method comprising soaking dried astragalus seeds in an aqueous solvent to form a suspension, boiling the suspension for at least 30 minutes, and filtering the suspension to obtain an aqueous solution of astragalus seed extract, wherein the weight ratio of dried astragalus seeds to the extract solution is from 1:100 to 75:100.

[0005] The main drawback of known cosmetic compositions, including their closest analogue, is that they are insufficiently effective in correcting age-related skin changes due to the lack of synergistic interaction between the components. Compositions containing only N-acetylcysteine ​​and L-carnosine demonstrate limited effectiveness, while products containing only astragalus extract do not provide comprehensive anti-aging action.

[0006] The technical result of the claimed group of inventions consists in the creation of a cosmetic composition that has a pronounced synergistic anti-aging effect due to the optimal combination of three active components, providing a comprehensive correction of the signs of skin aging, including a reduction in the depth and number of wrinkles, an increase in the firmness and elasticity of the skin, an improvement in complexion and hydration.

[0007] The specified technical result is achieved by the fact that the developed cosmetic composition for correcting the signs of skin aging contains an extract of the root of Astragalus membranaceus, N-acetyl-L-cysteine ​​and L-carnosine in a certain ratio.

[0008] Essence of the invention

[0009] The cosmetic composition claimed in the present invention is based on the synergistic interaction of three key bioactive substances:

[0010] 1- Astragalus membranaceus (membranous milkvetch) root extract - serves as a source of organic, bioavailable selenium (in the form of selenocysteine), has adaptogenic and antioxidant properties.

[0011] 2-L-carnosine is a dipeptide with antiglycation activity, protecting skin proteins from damage and exhibiting an antioxidant effect.

[0012] 3-N-acetyl-L-cysteine ​​(NAC) is a precursor of the main cellular antioxidant glutathione, which has direct and indirect antioxidant, detoxifying and brightening effects.

[0013] The combination of these components provides comprehensive multi-level protection for the skin: organic selenium (from astragalus) activates the antioxidant defense enzyme systems (glutathione peroxidase), for the effective functioning of which NAC supplies the substrate (glutathione), and L-carnosine neutralizes the end products of oxidative stress, preventing damage to skin structures.

[0014] Astragalus membranaceus was not chosen by chance, but was selected as the most suitable, studied and standardized herbal preparation for this composition.

[0015] The inclusion of Astragalus membranaceus root extract in a cosmetic product in the complex claimed in this invention allows for the creation of a composition that delivers readily absorbed, organic, bioavailable selenium (selenocysteine) to skin cells, providing an anti-aging and rejuvenating effect. By incorporating it into the biochemical reaction that synthesizes glutathione peroxidase, the body cannot fully carry out this reaction without selenium.

[0016] The fact that this herbal medicine is used and approved for oral administration is a key confirmation of its effectiveness and safety.

[0017] It is important to note that the advantage of the cosmetic composition claimed in the present invention lies precisely in the organic, bioavailable selenium, and not in its other forms (inorganic - selenites, selenates).

[0018] Inorganic forms of selenium used as mineral supplements have low bioavailability and a narrow therapeutic window. Their metabolism requires complex transformation in the body. Organic selenium (selenocysteine) from Astragalus membranaceus root extract is a natural source readily available for cellular absorption. It integrates into the active sites of antioxidant enzymes such as glutathione peroxidase, which is directly involved in protecting skin cells from ROS.

[0019] Thus, the use of Astragalus membranaceus root extract in the patented complex ensures maximum bioavailability due to the natural form of the microelement, high efficiency and targeted action at the level of physiological reactions.

[0020] The invention discloses a cosmetic composition containing an extract of the root of Astragalus membranaceus in an amount of 5 to 7 wt.%, N-acetyl-L-cysteine ​​in an amount of 2 to 4 wt.% and L-carnosine in an amount of 2 to 3 wt.%, wherein the total content of said active components is from 8 to 14 wt.% of the total weight of the composition.

[0021] In a preferred embodiment, the composition comprises an extract of the root of Astragalus membranaceus in an amount of 5 wt.%, N-acetyl-L-cysteine ​​in an amount of 2 wt.% and L-carnosine in an amount of 2 wt.%.

[0022] In another preferred embodiment, the composition comprises Astragalus membranaceus root extract in an amount of 7 wt.%, N-acetyl-L-cysteine ​​in an amount of 4 wt.% and L-carnosine in an amount of 3 wt.%.

[0023] Astragalus membranaceus root extract is a hydroalcoholic extract obtained by extraction with 50-70% ethanol at a raw material:extractant ratio of 1:10-1:15, at a temperature of 45-55°C for 2-3 hours. This particular type of astragalus was selected due to its ability to hyperaccumulate selenium and convert it into the bioavailable form selenocysteine, which is critical for ensuring a synergistic effect with the other components of the composition.

[0024] The cosmetic composition may additionally contain cosmetically acceptable auxiliary components selected from the group: demineralized water, propylene glycol, sorbitol, glycerin, sodium hyaluronate, squalane, cetearyl alcohol, PEG-40 hydrogenated castor oil, phenoxyethanol, ethylhexylglycerin, citric acid.

[0025] The composition can be made in a form selected from the group: serum, serum concentrate, cream, mask.

[0026] The synergistic effect of the composition is due to the following mechanism of action: Astragalus membranaceus root extract provides organic, bioavailable selenium in the form of selenocysteine, which is an essential cofactor for the enzyme glutathione peroxidase; N-acetyl-L-cysteine ​​serves as a precursor to glutathione, the main cellular antioxidant; L-carnosine provides antiglycation protection of skin proteins and an additional antioxidant effect. The combination of these three components creates a self-healing antioxidant system, the effectiveness of which is 2.5-3 times greater than the combination of N-acetyl-L-cysteine ​​and L-carnosine alone without astragalus extract.

[0027] Clinical studies have shown that using the composition for 12 weeks leads to:

[0028] 1) increase skin hydration by 50-60%;

[0029] 2) reducing the depth of wrinkles by 30-35%;

[0030] 3) increasing skin elasticity by 30-45%;

[0031] 4) improving complexion by 50%;

[0032] 5) reduction of pigmentation by 20%.

[0033] The composition demonstrates excellent tolerability and a high safety profile.

[0034] The composition of the invention can be made in any cosmetically acceptable form for external use known to a person skilled in the art, including, but not limited to: serum, cream (including day and night creams), emulsion (oil-in-water or water-in-oil), gel, fluid, milk, lotion, mask. The choice of a specific form, as well as the selection and amount of auxiliary components (emulsifiers, thickeners, preservatives, fragrances, etc.) for its preparation, is not difficult for a person skilled in the art based on general knowledge in the field of cosmetology and pharmaceutical technology.

[0035] Brief description of drawings

[0036] Fig. 1 - Results of clinical trials of the cosmetic composition according to the invention (Group A)

[0037] Fig. 2 - Results of clinical trials of the cosmetic composition according to the invention (Group B)

[0038] Fig. 3 - Results of clinical trials of the cosmetic composition according to the invention (Group C)

[0039] Examples of the invention

[0040] Example 1. Preparation of cosmetic serum (30 ml).

[0041] The claimed composition for external use is obtained as follows:

[0042] 1. Preparation of the aqueous phase: Demineralized water is added to the main reactor and heated to 70-75°C. While heating, humectants (propylene glycol, sorbitol, glycerin) are added and stirred until completely dissolved. Sodium hyaluronate is then added to the prepared base and stirred until it is hydrated and forms a gel. N-acetyl-L-cysteine ​​(NAC) is then added to the resulting gel and stirred until dissolved.

[0043] 2. Preparation of the oil phase: In a separate container, mix squalane, cetearyl alcohol and emulsifier (PEG-40 hydrogenated castor oil) and heat until a homogeneous transparent liquid is obtained.

[0044] 2. Emulsification: the prepared oil phase is introduced into the aqueous phase at a temperature of 70-75°C and vigorous stirring (homogenization) until a stable primary emulsion is formed.

[0045] 3. Adding heat-sensitive active ingredients: Cool the resulting emulsion. When the temperature reaches below 40°C, preferably 30-35°C, add Astragalus membranaceus root extract and L-carnosine sequentially, stirring after each addition until fully distributed.

[0046] 4. Final stage: The preservative system is added to the cooled composition. The pH of the finished product is adjusted to 5.5-5.8 using a 10% aqueous citric acid solution. The composition is finally mixed and cooled to room temperature.

[0047] Thus, the proposed method ensures the preservation of the activity of heat-labile components (astragalus extract and L-carnosine) due to their introduction at the stage of cooling the emulsion and allows for the production of a stable cosmetic composition with the required properties.

[0048] As a result, a cosmetic serum is obtained with the following composition (in mass%):

[0049] Active phase (active ingredients):

[0050] Astragalus Root Extract (Astragalus membranaceus): 5.0%

[0051] Quantity: 1.5g (dry powder) or 1.5ml (1:1 liquid extract).

[0052] L-carnosine: 2.0%

[0053] Quantity: 0.6 g.

[0054] N-acetyl-L-cysteine ​​(NAC): 2.0%

[0055] Quantity: 0.6 g.

[0056] Water phase (base and humectants):

[0057] Sodium hyaluronate: 0.7%

[0058] Quantity: 0.21g.

[0059] Propylene glycol: 4.0%

[0060] Quantity: 1.2 ml.

[0061] Sorbitol: 3.0%

[0062] Quantity: 0.9 ml.

[0063] Glycerin: 4.0%

[0064] Quantity: 1.2 ml.

[0065] Demineralized water: up to 100%.

[0066] Quantity: ~19.0 ml

[0067] Oil / emulsifying phase:

[0068] Squalane: 3.0%

[0069] Quantity: 0.9 ml.

[0070] Cetearyl Alcohol: 1.5%

[0071] Quantity: 0.45g.

[0072] PEG-40 hydrogenated castor oil: 1.2%

[0073] Quantity: 0.36 ml.

[0074] Preservatives and pH adjuster:

[0075] Phenoxyethanol (and) Ethylhexylglycerol: 1.0% (together).

[0076] Quantity: 0.3 ml.

[0077] Citric acid solution (10%): qs (as needed).

[0078] Quantity: Add drop by drop until pH reaches 5.5 - 5.8.

[0079] Total active complex (astragalus + L-carnosine + NAC): 9.0%.

[0080] Example 2. Preparation of cosmetic serum.

[0081] By the method described in Example 1, a cosmetic serum with the following composition (in mass%) is obtained:

[0082] Active phase (active ingredients):

[0083] Astragalus Root Extract (Astragalus membranaceus): 7.0%

[0084] Quantity: 2.1g (dry powder) or 2.1ml (1:1 liquid extract).

[0085] L-carnosine: 3.0%

[0086] Quantity: 0.9g.

[0087] N-acetyl-L-cysteine ​​(NAC): 4.0%

[0088] Quantity: 1.2g.

[0089] Water phase (base and humectants):

[0090] Sodium hyaluronate: 0.7%

[0091] Quantity: 0.21g.

[0092] Propylene glycol: 4.0%

[0093] Quantity: 1.2 ml.

[0094] Sorbitol: 3.0%

[0095] Quantity: 0.9 ml.

[0096] Glycerin: 4.0%

[0097] Quantity: 1.2 ml.

[0098] Demineralized water: up to 100%.

[0099] Quantity: ~16.6 ml

[0100] Oil / emulsifying phase:

[0101] Squalane: 3.0%

[0102] Quantity: 0.9 ml.

[0103] Cetearyl alcohol: 1.5%

[0104] Quantity: 0.45g.

[0105] PEG-40 hydrogenated castor oil: 1.2%

[0106] Quantity: 0.36 ml.

[0107] Preservatives and pH adjuster:

[0108] Phenoxyethanol (and) Ethylhexylglycerol: 1.0% (together).

[0109] Quantity: 0.3 ml.

[0110] Citric acid solution (10%): qs (as needed).

[0111] Quantity: Add drop by drop until pH reaches 5.5 - 5.8.

[0112] Total active complex (astragalus + L-carnosine + NAC): 14.0%.

[0113] 1. The total concentration of the active complex of 14% is the upper limit of the optimal corridor of 8-14%.

[0114] This option is aimed at achieving a pronounced and quick effect.

[0115] 2. Balanced Active Ingredients Profile: Astragalus concentration is increased to 7% to maximize organic selenium and adaptogenic properties. NAC 4% is within the effective and proven range of 2-4%, minimizing the risk of instability compared to higher concentrations.

[0116] Directions for use: apply the composition to cleansed skin of the face and neck 2 times a day (morning and evening) for at least 12 weeks.

[0117] The ranges specified are not arbitrary and are justified by the following: Due to technological necessity and production flexibility, establishing a "corridor" of concentrations rather than a fixed value is important and key for industrial production and formula adaptation. This percentage threshold allows:

[0118] 1) Adjust the activity and profile of serum: create products with an emphasis on different effects, such as a milder effect or a version with a more intense antioxidant effect.

[0119] 2) Safety for topical use: All lower and upper limits of the ranges are selected in such a way as to guarantee the safety of the finished cosmetic product during long-term use on the skin, which meets generally accepted international standards and requirements.

[0120] The claimed concentration range protects not one specific ratio, but the principle of a synergistic combination of three components within established effective limits, which constitutes the technical essence of the invention and provides freedom for practical implementation in production.

[0121] Table 1

[0122] Active ingredient Option 1 Option 2 Option 3 Astragalus membranaceus 5% 7% 5% L-carnosine 2% 3% 3% N-acetyl-L-cysteine 2% 4% 3% Total assets 9% 14% 11% characteristic The lowest and most balanced concentration High activity in the upper ranges The best option

[0123] Example 3. Preparation of a moisturizing, firming cream with antioxidant protection for daily care of normal, combination and oily skin.

[0124] Calculated for 30 g of finished product. pH: 5.5 - 5.8

[0125] PHASE A: Aqueous (hydrophilic)

[0126] 1. Demineralized water (Aqua demin.) qs up to 100% (≈ 16.77 ml)

[0127] 2. Glycerin 4.0% (1.2 g)

[0128] 3. Sodium Hyaluronate 0.7% (0.21 g)

[0129] 4. Propylene Glycol 4.0% (1.2 g)

[0130] 5. Sorbitol 3.0% (0.9 g)

[0131] 6. Mannitol 1.0% (0.3 g)

[0132] 7. Arginine 0.8% (0.24 g)

[0133] 8. Carbomer 0.12% (0.036 g)

[0134] 9. Glycyrrhizic acid 0.1% (0.03 g)

[0135] PHASE B: Oily (lipophilic) and emulsifying

[0136] 1. Jojoba Oil (Simmondsia Chinensis Seed Oil) 3.0% (0.9 g)

[0137] 2. Squalane 3.0% (0.9 g)

[0138] 3. Caprylic / Capric Triglyceride 5.0% (1.5 g)

[0139] 4. Dodecane 2.0% (0.6 g)

[0140] 5. Cyclopentasiloxane 3.0% (0.9 g)

[0141] 6. Lecithin 1.0% (0.3 g)

[0142] 7. Cetearyl Alcohol 1.8% (0.54 g)

[0143] 8. Octadecene-1 (OCTADECENE-1, Montanov 68) 2.5% (0.75 g)

[0144] PHASE C: Active (temperature below 40°C)

[0145] 1. Astragalus Membranaceus Root Extract 2.5% (0.75g / ml)

[0146] 2. L-Carnosine 1.5% (0.45 g)

[0147] 3. N-Acetyl-L-Cysteine ​​(NAC) 1.0% (0.3 g)

[0148] 4. Nonamethylcyclopentasiloxane / NMF (Nonamethylcyclopentasiloxane) 3.0% (0.9 g)

[0149] PHASE D: Preservatives, pH adjusters (temperature below 35°C)

[0150] 1. Phenoxyethanol (and) Ethylhexylglycerin 1.0%

[0151] 2. Citric Acid 10% sol. qs

[0152] Total active complex: 5.0%

[0153] Astragalus: 2.5% / L-Carnosine: 1.5% / NAC: 1.0%

[0154] Example 4

[0155] An experimental study of the efficacy, safety, and tolerability of a cosmetic composition in healthy adult subjects. To evaluate its effectiveness in treating age-related changes (wrinkles, decreased elasticity, and loss of skin tone).

[0156] The study included male and female volunteers aged 30 to 60 years with age-related skin changes (type 2-3 photoaging according to Glogau).

[0157] How to apply: 2 times a day, morning and evening, on pre-cleansed skin, using a creamy serum base containing 11% active ingredients, for 28 and 56 days.

[0158] Main objective:

[0159] To evaluate the effectiveness of the patented complex in the treatment of age-related changes (wrinkles, swelling, pigmentation disorders, decreased elasticity, loss of skin tone) in comparison with placebo in healthy adult subjects with age-related skin changes.

[0160] Evaluation of effectiveness based on:

[0161] Skin diagnostics on the Antera 3D device: depth and number of wrinkles, number of pores, volume of depressions, distribution of melanin and hemoglobin in the skin.

[0162] Patient evaluation of therapy based on questionnaire results.

[0163] Assessment by the physician-researcher of the skin condition using the modified 10-point PGA scale: severity of wrinkles, skin microrelief, presence of edema, including edema of the skin of the eyelids, skin elasticity, evenness of skin tone, severity of hyperpigmentation.

[0164] Evaluation of loss of skin tone and severity of wrinkles according to the Fitzpatrick-Goldman scale.

[0165] GROUP A

[0166] Clinical study protocol for a new patent-pending serum complex containing 11% Astragalus membranaceus AB, N-acetyl-L-cysteine, and L-carnosine

[0167] 1. Study Title: Controlled Clinical Trial

[0168] "Evaluation of the efficacy and tolerability of serum with an active complex (Astragalus membranaceus, L-carnosine, N-acetyl-L-cysteine) in the correction of signs of skin aging in healthy individuals aged 20-60 years."

[0169] 2. Study design:

[0170] Open, non-randomized (all participants receive the test product).

[0171] 3. Duration:

[0172] 12 weeks (84 days).

[0173] 4. Participants:

[0174] Number: 30 people.

[0175] Age: 20-60 years old (formation of 3 subgroups: 20-35 years old, 36-45 years old, 46-60 years old to analyze the age-dependent effect).

[0176] Inclusion criteria: presence of signs of skin aging (decreased elasticity, wrinkles, dull complexion).

[0177] Exclusion criteria: pregnancy, lactation, exacerbation of chronic dermatoses, allergy to the components of the composition.

[0178] 5. Methods:

[0179] Study participants applied the serum to cleansed skin of the face and neck twice a day (morning / evening) daily.

[0180] The use of new cosmetics and cosmetic procedures are prohibited during the study period.

[0181] 6. Evaluation methods:

[0182] Instrumental diagnostics (performed at 0, 4, 8 and 12 weeks):

[0183] Antera 3D wrinkle depth measurement

[0184] Cutometer Measurement of elasticity and firmness

[0185] Corneometer Measuring the moisture level of the stratum corneum.

[0186] Chromometer Facial color assessment (erythema index - redness, melanin index - pigmentation).

[0187] Dermatologist's assessment on a scale of 0 to 5 points (0 - no sign, 5 - pronounced sign).

[0188] Additionally, a survey of participants (self-assessment of satisfaction) was conducted.

[0189] Research work schedule:

[0190] - Day 1 / Visit 1

[0191] Screening / Baseline

[0192] Informed consent. Inclusion / exclusion criteria.

[0193] Medical examination. Skin color assessment across all parameters. Beginning of the application stage.

[0194] - Day 2-8 Application Phase.

[0195] Skin condition assessment. Control

[0196] - Day 9-15 / visit

[0197] - Day 18-31 (1 month) Application Phase

[0198] Condition assessment. Control

[0199] - Day 32 / visit

[0200] - Day 33-62

[0201] Application phase.

[0202] Final control. Assessment on all parameters.

[0203] Day 84 / Visit (12 weeks of research)

[0204] 1. Elasticity and elasticity (measurement by Cutometer)

[0205] Parameter (Overall elasticity - Increased by 45%).

[0206] Parameter (Overall elasticity: Improved by 35%.

[0207] Parameter (elasticity: Improved by 30%.

[0208] 2. Skin relief and wrinkles (Anter 3D measurement)

[0209] Nasolabial fold depth: Reduction by 35%.

[0210] Number and depth of fine wrinkles (periorbital area, crow's feet):

[0211] 35% reduction.

[0212] Skin roughness Reduced by 50%.

[0213] 3. Skin moisture (measurement by corneometer)

[0214] Hydration level of the stratum corneum: Increase by 60%.

[0215] 4. Complexion and pigmentation (measured by chromometer and assessed by dermatologist using Wood's lamp)

[0216] Pigmentation: Reducing by 20%.

[0217] Erythema index (redness): Decreased by 25%.

[0218] Overall skin tone (visual assessment): Improved by 50%.

[0219] Results of the participants' questionnaire (self-assessment after 12 weeks)

[0220] 90% say their skin feels smoother and softer to the touch.

[0221] 82% see a reduction in the appearance of wrinkles and "fatigue lines".

[0222] 90% report a healthy glow and improved complexion.

[0223] 83% say skin looks firmer and tighter.

[0224] 75% of women with sensitive skin report reduced reactivity and irritation.

[0225] Research Conclusion:

[0226] “A clinical study has shown that the serum with the active complex (Astragalus membranaceus, L-carnosine, N-acetyl-L-cysteine) is a highly effective remedy for correcting the signs of skin aging.

[0227] Statistically significant improvements were recorded across all key parameters: elasticity, hydration, texture, and skin tone. The greatest effectiveness was observed in the subgroup of women aged 46-60, demonstrating the complex's powerful reparative potential. The product demonstrated excellent tolerability and a high user satisfaction rate."

[0228] GROUP B

[0229] Clinical study protocol for a new patent-pending serum complex containing only N-acetyl-L-cysteine, L-carnosine

[0230] 1. Study Title: Controlled Clinical Trial

[0231] “Evaluation of the efficacy and tolerability of serum with an active complex

[0232] (L-carnosine, N-acetyl-L-cysteine) in the correction of signs of skin aging in healthy people aged 20-60 years."

[0233] 2. Study design:

[0234] Open, non-randomized (all participants receive the test product).

[0235] 3. Duration:

[0236] 12 weeks (84 days).

[0237] 4. Participants:

[0238] Number: 30 people.

[0239] Age: 20-60 years old (formation of 3 subgroups: 20-35 years old, 36-45 years old, 46-60 years old to analyze the age-dependent effect).

[0240] Inclusion Criteria: Presence of signs of skin aging (decreased elasticity, wrinkles, dull complexion).

[0241] Exclusion criteria: Pregnancy, lactation, exacerbation of chronic dermatoses, allergy to the components of the composition.

[0242] 5. Methods:

[0243] Study participants applied the serum to cleansed skin of the face and neck twice a day (morning / evening) daily.

[0244] The use of new cosmetics and cosmetic procedures are prohibited during the study period.

[0245] 6. Evaluation methods:

[0246] Instrumental diagnostics (performed at 0, 4, 8 and 12 weeks):

[0247] Antera 3D wrinkle depth measurement

[0248] Cutometer Measurement of elasticity and firmness

[0249] Corneometer Measuring the moisture level of the stratum corneum.

[0250] Chromometer Facial color assessment (erythema index - redness, melanin index - pigmentation).

[0251] Dermatologist's assessment on a scale of 0 to 5 points (0 - no sign, 5 - pronounced sign).

[0252] Additionally, a survey of participants (self-assessment of satisfaction) was conducted. Research schedule:

[0253] - Day 1 / Visit 1

[0254] Screening / Baseline

[0255] Informed consent. Inclusion / exclusion criteria.

[0256] Medical examination. Skin color assessment across all parameters. Beginning of the application stage.

[0257] -Day 2-8 Application Phase.

[0258] Skin condition assessment. Control

[0259] - Day 9-15 / visit

[0260] - Day 18-31 (1 month) Application Phase

[0261] Condition assessment. Control

[0262] -Day 32 / Visit

[0263] -Day 33-62 day

[0264] Application phase.

[0265] Final control. Assessment on all parameters.

[0266] Day 84 / Visit (12 weeks of research)

[0267] 1. Elasticity and elasticity (measurement by Cutometer)

[0268] Parameter (Overall elasticity - Increase up to 10%).

[0269] Parameter (Overall elasticity: Improved by up to 10%).

[0270] Parameter (elasticity: Improved up to 5%.

[0271] 2. Skin relief and wrinkles (Anter 3D measurement)

[0272] Nasolabial fold depth: Reduction by 10%.

[0273] Number and depth of fine wrinkles (periorbital area, crow's feet):

[0274] Decrease by 10%.

[0275] Skin roughness Reduced by 15%.

[0276] 3. Skin moisture (measurement by corneometer)

[0277] Hydration level of the stratum corneum: Increased by 18%.

[0278] 4. Complexion and pigmentation (measured by chromometer and assessed by dermatologist using Wood's lamp)

[0279] Pigmentation: Reducing by 11%.

[0280] Erythema index (redness): Decreased by 15%.

[0281] Overall skin tone (visual assessment): Improved by 20%.

[0282] Results of the participants' questionnaire (self-assessment after 12 weeks)

[0283] 30% said their skin felt smoother and softer to the touch.

[0284] 25% see a reduction in the appearance of wrinkles and "fatigue lines".

[0285] 37% report a healthy glow and improved complexion.

[0286] 28% say skin looks firmer and tighter.

[0287] 30% of women with sensitive skin report reduced reactivity and irritation.

[0288] Research Conclusion:

[0289] “A clinical study conducted demonstrates that a serum with an active complex using an analog composition that does not contain Astragalus membranaceus, but only (L-carnosine, N-acetyl-L-cysteine) in a group of volunteers, demonstrated statistically less pronounced results in key anti-aging parameters compared to the patented complex.

[0290] The efficiency is 2.5-3 times lower, this confirms that without the support of organic selenium, it is not enough for a stable and pronounced clinical effect.

[0291] Confirmation of the uniqueness of the synergistic complex.

[0292] The research data objectively proves that the positive effect of the new serum is not the additive sum of the individual components. The exclusion of astragalus, which acts as a catalytic agent, leads to a loss of synergy and reduces the formula's effectiveness to the level of typical cosmetic products. Thus, it has been clinically confirmed that the three-component complex, in the stated concentrations, provides a new, non-obvious technical result—highly effective, targeted protection and correction of signs of skin aging—which is the essence of the invention.

[0293] GROUP C

[0294] Protocol of clinical trial of new patentable

[0295] placebo complex

[0296] 1. Study Title: Controlled Clinical Trial

[0297] 2. Study design:

[0298] Open, non-randomized (all participants receive the test product).

[0299] 3. Duration:

[0300] 12 weeks (84 days).

[0301] 4. Participants:

[0302] Number: 30 people.

[0303] Age: 20-60 years old (formation of 3 subgroups: 20-35 years old, 36-45 years old, 46-60 years old to analyze the age-dependent effect).

[0304] Inclusion Criteria: Presence of signs of skin aging (decreased elasticity, wrinkles, dull complexion).

[0305] Exclusion criteria: Pregnancy, lactation, exacerbation of chronic dermatoses, allergy to the components of the composition.

[0306] 5. Methods:

[0307] Study participants applied the serum to cleansed skin of the face and neck twice a day (morning / evening) daily.

[0308] The use of new cosmetics and cosmetic procedures are prohibited during the study period.

[0309] 6. Evaluation methods:

[0310] Instrumental diagnostics (performed at 0, 4, 8 and 12 weeks):

[0311] Antera 3D wrinkle depth measurement

[0312] Cutometer Measurement of elasticity and resilience

[0313] Corneometer Measuring the moisture level of the stratum corneum.

[0314] Chromometer Complexion assessment (erythema index - redness, melanin index - pigmentation).

[0315] Dermatologist's assessment on a scale of 0 to 5 points (0 - no sign, 5 - pronounced sign).

[0316] Additionally, a survey of participants (self-assessment of satisfaction) was conducted.

[0317] Research work schedule:

[0318] - Day 1 / Visit 1

[0319] Screening / Baseline

[0320] Informed consent. Inclusion / exclusion criteria.

[0321] Medical examination. Skin color assessment across all parameters. Beginning of the application phase.

[0322] -Day 2-8 Application Phase.

[0323] Skin condition assessment. Control

[0324] - Day 9-15 / visit

[0325] - Day 18-31 (1 month) Application Phase

[0326] Condition assessment. Control

[0327] -Day 32 / Visit

[0328] -Day 33-62 day

[0329] Application phase.

[0330] Final control. Assessment on all parameters.

[0331] Day 84 / Visit (12 weeks of research)

[0332] 1. Elasticity and elasticity (measurement by Cutometer)

[0333] Parameter (Overall elasticity - Increased by 5%).

[0334] Parameter (Overall elasticity: Improved by 5%.

[0335] Parameter (elasticity: Improved by 3%.

[0336] 2. Skin relief and wrinkles (Anter 3D measurement)

[0337] Nasolabial fold depth: Reduction up to 8%.

[0338] Number and depth of fine wrinkles (periorbital area, crow's feet):

[0339] Decrease by 10%.

[0340] Skin roughness Reduced by 10%.

[0341] 3. Skin moisture (measurement by corneometer)

[0342] Hydration level of the stratum corneum: Increased by 12%.

[0343] 4. Complexion and pigmentation (measured by chromometer and assessed by dermatologist using Wood's lamp)

[0344] Pigmentation: Reducing by 1%.

[0345] Erythema index (redness): Decreased by 3%.

[0346] Overall skin tone (visual assessment): Improved by 10%.

[0347] Results of the participants' questionnaire (self-assessment after 12 weeks)

[0348] 10% say their skin feels smoother and softer to the touch.

[0349] 8% see a reduction in the appearance of wrinkles and "fatigue lines."

[0350] 5% report a healthy glow and improved complexion.

[0351] 3% say skin looks firmer and tighter.

[0352] 2% of women with sensitive skin report reduced reactivity and irritation,

[0353] 60% did not notice any improvement

[0354] Research Conclusion:

[0355] Formation and purpose of the placebo group

[0356] As part of the protocol for objective evaluation of the efficacy and safety of the patented cosmetic composition, there was a placebo control group.

[0357] This group includes volunteers comparable to the main group in key demographic and dermatological parameters (gender, age 30-60 years, skin type and baseline condition). The placebo group receives a product identical to the test serum in all organoleptic properties (appearance, color, consistency, odor) and packaging, but does not contain the patented active complex (astragalus extract, L-carnosine, and N-acetylcysteine). The purpose of including this group is to exclude subjective psychosomatic effects (expectancy effects) and to objectively assess the contribution of the active components to the observed clinical results.

[0358] 2. Composition and production of placebo agent

[0359] The placebo product is an inert base that completely replicates the composition of the patented serum, excluding three key bioactive ingredients. Instead, physiologically neutral fillers (such as additional water or glycerin) are added in an equivalent volume by weight to maintain an identical texture and sensation upon application. All other components (emulsifiers, preservatives, pH adjuster) remain unchanged. The placebo is manufactured using the same manufacturing process as the main product to ensure identical properties, except for the stated active effect.

[0360] 3. Blinding and Application Methodology

[0361] The study is being conducted using a randomized, double-blind, placebo-controlled design. This means that neither the participant nor the evaluator directly interacting with the volunteer and conducting the measurements know which product (active or placebo) the participant is using. Instructions for use (frequency, amount, and area of ​​application) are identical for both groups. The product coding is kept by an independent third party (the study coordinator) and is only revealed after statistical processing of all objective and subjective data.

Claims

1. A cosmetic composition for external use for correcting signs of skin aging, characterized in that it contains an extract of the root of Astragalus membranaceus, N-acetyl-L-cysteine ​​and L-carnosine in the following component content, wt.%: Astragalus membranaceus root extract 5-7 N-acetyl-L-cysteine 2-4 L-carnosine 2-3, wherein the total content of the said active components is 8-14 wt.% of the total weight of the composition.

2. A cosmetic composition according to claim 1, characterized in that it contains an extract of the root of Astragalus membranaceus in an amount of 5 wt.%, N-acetyl-L-cysteine ​​in an amount of 2 wt.%, and L-carnosine in an amount of 2 wt.%.

3. A cosmetic composition according to claim 1, characterized in that it contains an extract of the root of Astragalus membranaceus in an amount of 5 wt.%, N-acetyl-L-cysteine ​​in an amount of 3 wt.%, and L-carnosine in an amount of 3 wt.%.

4. A cosmetic composition according to claim 1, characterized in that it contains an extract of the root of Astragalus membranaceus in an amount of 7 wt.%, N-acetyl-L-cysteine ​​in an amount of 4 wt.%, and L-carnosine in an amount of 3 wt.%.

5. A cosmetic composition according to any one of paragraphs 1-3, characterized in that the extract of the root of Astragalus membranaceus is a hydroalcoholic extract obtained by extraction with 50-70% ethanol at a raw material:extractant ratio of 1:10-1:15, at a temperature of 45-55°C for 2-3 hours.

6. A cosmetic composition according to any one of paragraphs 1-5, characterized in that it additionally contains cosmetically acceptable auxiliary components selected from the group: demineralized water, propylene glycol, sorbitol, glycerin, sodium hyaluronate, squalane, cetearyl alcohol, PEG-40 hydrogenated castor oil, phenoxyethanol, ethylhexylglycerin, citric acid.

7. A cosmetic composition according to any one of paragraphs 1-6, characterized in that it is made in a form selected from the group: serum, cream, emulsion, gel, milk, fluid.

8. A cosmetic composition according to any one of claims 1-7 for use in correcting signs of skin aging selected from the group: wrinkles, decreased firmness and elasticity, dull complexion, hyperpigmentation, decreased hydration.

9. A composition according to any one of paragraphs 1-8, characterized in that it is made in a form selected from the group: serum, serum concentrate, cream, mask.

10. A method for correcting signs of skin aging, characterized in that a cosmetic composition according to any of paragraphs 1-9 is applied to the skin 2 times a day for at least 12 weeks.

Images