Clinical Studies

Clinical evidence behind every formula

At the core of AWvi lies a rigorous, science-driven method. Every formula undergoes independent clinical trials designed to validate real, measurable results.

Here you can explore our study design, the parameters evaluated, and the improvements observed over eight weeks — from wrinkle reduction and enhanced radiance to increased hydration and a stronger skin barrier.

Clinical efficacy
Dermatological safety
Compatibility and stability tests

Aim of the study

We have substantiated our efficacy claims through clinical studies, performed by a third party (Complife Group1)

The study has been designed — in the current framework proposed by Commission Regulation (EU) No 655/2013 — to assess the all-encompassing effectiveness of The Skin Method's full product range in addressing multiple benefits related to skin aging and skin health. In particular, the study aims to explore the synergistic impact of using The Skin Biotic nutraceutical in combination with the three cosmeceutical (topical) products—The Gentle Cleanser, The Power Serum, The Active Cream.

Subjects

Multicentric, double-blind, randomized, placebo-controlled study.

96 healthy subjects, divided into 4 groups of 24 subjects each, enrolled by a board-certified dermatologist, according to specific inclusion and exclusion criteria:

- Group 1: 24 subjects are treated with The Skin Biotic + Placebo topical solutions
- Group 2: 24 subjects are treated with Placebo supplement + Placebo topical solutions
- Group 3: 24 subjects are treated with The Skin Biotic + AWvi topical solutions
- Group 4: 24 subjects are treated with Placebo supplement + AWvi topical solutions

Main inclusion criteria: Age range: 45 to 65 years, with an average age of 55 years; Including sensitive skin; Skin ageing from mild to moderate.

8 weeks study duration; Assessment of the product effects after 4- and 8-week use.

Measured parameters and results

Wrinkles and Fine Lines reduction

Skin surface (i.e. wrinkle depth, volume, skin roughness, etc.) is quantitatively assessed by Primos CR SF (Canfield Scientific Europe, BV, Utrecht, Netherlands). Primos CR SF is a non-contact in vivo skin measurement device based on structured light projection. In conjunction with a comprehensive 3-D measurement and evaluation software, the sensor allows to evaluate skin surface properties.

In this study:
- Sa parameter (related to skin smoothness) is measured in the crow’s feet area at T0/T4/T8
- Crow’s feet wrinkle depth is measured at T0/T1h/T4/T8.

Skin profilometry by means of Primos CR SF analysis:

A - The technique
Primos CR SF (small field) is a 3D scanner that create a point cloud (set of vertices in a three-dimensional coordinate system) of geometric samples on the surface of the subject. These points are then used to extrapolate the shape of the subject (a process called reconstruction). Like cameras, 3D-scanner has a cone-like field of view, and like cameras, they can only collect information about surfaces that are not obscured. While a camera collects color information about surfaces within its field of view, 3D scanners collect distance information about surfaces within its field of view. The “picture” produced by a 3D scanner describes the distance to a surface at each point in the picture (see the image in the insert).

B - Calculation of wrinkle depth
It is calculated the height of wrinkles in the sampling lengths: this calculation is done on the sectional picture (wrinkle depth vs. section).

C - Calculation of skin smoothness (Sa parameter)
The surface roughness is calculated through the arithmetic roughness (Sa parameter). Sa is the arithmetic mean of the surface roughness and it is a vertical parameter. This means it describes the roughness in vertical direction. The parameter is used to evaluate the surface smoothness.

BEFORE

AFTER

Clinically proven results

Wrinkles and fine lines reduction

Up to 45% wrinkles and fine lines reduction 1

Up to 34% reduction after 1 hour 1

Over x5.1 improvement after 8 weeks with the full 4-product Skin Method 2

Target: 63 years old subject with deep wrinkles
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

1. Results from the reference group that used all four active products of 'The Skin Method' in combination.
2. Comprehensive improvement provided by the synergy of all four active products of 'The Skin Method', compared to a combination of placebo solutions composed of one supplement and three topical products.

Skin radiance improvement

Skin radiance (or skin brightness) is the ability of the skin to reflect the light and it is measured using the gloss parameter (taken using the spectrophotometer/colorimeter CM-700D (Konica-Minolta). The instrument emits diffuse light that reaches the skin through an opening located at the extreme of the lighting sphere.

A sensor located at 8° compared to the vertical axis of the opening detects then the reflected light and calculates a parameter known as ‘gloss’. The gloss value is used in the management of the brilliance of the colour.

Skin radiance is measured at T0/T1h/T4/T8.

BEFORE

AFTER

Clinically proven results

Radiance improvement

Up to 68% radiance improvement 1

Over x5 improvement after 8 weeks with the full 4-product Skin Method 2

Target: 53 years old subject
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

Skin moisturisation improvement

Skin moisturisation (and hydration) is evaluated by means of Corneometer® measurement. This measurement is based on the completely different dielectric constant of water (81) and other substances (mostly < 7). The measuring capacitor shows changes of capacitance according to the moisture content of the skin.

A metallic lamina separates the metallic tracks (gold) in the probe head from the skin in order to prevent current conduction in the measured area. An electric field between the tracks with alternating attraction develops. One track builds up a surplus of electrons (minus charge) the other a lack of electrons (plus charge). The scatterfield penetrates the very first layer of the skin (10-20 μm) during the measurement and the capacitance is determined.

Skin moisturisation is measured at T0/T1h/T4/T8.

BEFORE

AFTER

Clinically proven results

Moisturisation improvement

Up to 60% moisturisation increase 1

Over x3.2 improvement after 8 weeks with the full 4-product Skin Method 2

Target: 59 years old subject
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

Skin elasticity and firmness improvement

Skin elasticity measurement is based on the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®MPA 580, Courage+Khazaka, electronic GmbH). During the suction/elongation phase the instrument generates, in fact, a constant negative pressure (450 mbar) able to aspirate the skin inside the measurement probe.

The suction phase is followed by the release phase, in which the pressure inside the probe is switched to 0 mbar allowing the skin recovery after the elongation phase. An optical measurement system evaluates the depth of the skin inside the probe in the two phases of the measurement, the obtained data are then elaborated and showed graphically and numerically in order to calculate the viscoelastic properties of the skin.

In this study, the following parameter are measured:

- R2 parameter (gross elasticity or overall elasticity): it is the ratio between the residual deformation and the maximum elongation of the skin (Ua/Uf) and it indicates the ability of the skin to return to its original state of recovery after a stressing event. Closer the value is to 1, more elastic is the skin.

- R0 parameter (skin distensibility): it is the first max amplitude of the curve (Uf) and it represents the passive behavior of the skin to a force (i.e. gravity). A reduction of R0 parameter indicates an improvement of the skin ability to oppose to the deformation imposed by the probe during the suction phase, than can be expressed as an improvement of skin firmness.

Skin elasticity and firmness is measured at T0/T4/T8.

BEFORE

AFTER

Clinically proven results

Elasticity improvement

Up to 19% elasticity increase 1

Over x5.5 improvement after 8 weeks with the full 4-product Skin Method 2

Target: 46 years old subject
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

Skin barrier function improvement

Skin barrier function is measured at T0/T4/T8 using a Tewameter® TM 300 (Courage+Khazaka, electronic GmbH). The following equation which represents the Diffusion law (discovered by Adolf Fick in 1855) is the basis for the measurement:

Where:

A=surface in m² / water transported (in g) - / time (h) - / diffusion constant (=0.0877 g/mhmm Hg) / vapor pressure of the atmosphere (mm Hg) - / distance from skin surface to point of measurement (m)
The diffusion flow dm/dt indicates the mass per cm² which is transported in a specific period of time. It is proportional to the area A and the change of concentration per distance (dp/dx).

D is the diffusion coefficient of water vapor in the air. This law is only valid within a homogenous diffusion zone, which is approximately formed by a hollow cylinder. The resulting density gradient is measured indirectly by two pairs of sensors (temperature and relative humidity) and is analyzed by a microprocessor.

The measuring head of the probe is a narrow hollow cylinder (10 mm diameter and 20 mm height), in order to minimize influences of air turbulence inside the probe.

BEFORE

AFTER

Clinically proven results

Skin barrier function improvement

Up to 28% skin barrier function improvement 1

Over x5.6 improvement after 8 weeks with the full 4-product Skin Method 2

Target: 65 years old subject
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

Skin sebum reduction

According to this method the sebum on skin is collected on a 64 mm2 mat synthetic tape contained in a cassette, then the measuring head of the cassette is inserted into the aperture of the device, where a photocell measures the transparency. The light transmission represents the sebum content on the surface of the measuring area. A microprocessor calculates the result, which is shown on the display in µg sebum/cm² of the skin.

Skin sebum is measured at T0/T4/T8.

BEFORE

AFTER

Clinically proven results

Skin sebum reduction

Up to 65% skin sebum reduction 1

Over x2.3 improvement after 8 weeks with the full 4-product Skin Method 2

Target: 65 years old subject
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

Skin impurities removal

On pictures acquired by Visia®-CR (Canfield Scientific) an image analysis with a dedicated software is carried out in order to evaluate Protoporphyrin distribution. Protoporphyrin is produced by bacteria and a decrease of its distribution can be related to impurities removal.

Protoporphyrin distribution is measured at T0/T4/T8.

Protoporphyrin distribution over the face:

BEFORE

AFTER

Clinically proven results

Skin impurities removal

Up to 32% skin impurities decrease 1

Over x2.7 improvement after 8 weeks with the full 4-product Skin Method 2

Target: 50 years old subject
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

Skin pores reduction

On pictures acquired by Visia®-CR (Canfield Scientific) an image analysis with a dedicated software is carried out in order to evaluate pore dimension (size). For each volunteer, the measurement is carried out in a standardized area of the face.

Pore dimension measured at T0/T4/T8.

BEFORE

AFTER

Clinically proven results

Skin pores reduction

Up to 16% skin pores reduction 1

Target: 57 years old subject
Protocol: use of The Skin Biotic combine with 3 placebo topicals for 8 weeks

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

1. Results from the reference group using three AWvi active topicals with one placebo supplement.
2. Comprehensive improvement provided by the three AWvi active topical products, compared to a combination of placebo solutions composed of one supplement and three topical products.

Skin microbiome improvement

The skin microbiome analysis is based on the metagenomic analysis of the 16S rRNA gene. 16S rRNA gene was chosen since this gene is present in all bacterial (prokaryotic) cells genetic material, but not in human (eukaryotic) cells. Skin microbiota is collected by brushing a defined skin area with a swab, a non-invasive method allowing to collect the bacteria on the skin surface.

The second step of the analysis pipeline consists in isolating the bacterial DNA from other components of the sample (human DNA, sebum, dead skin cells, atmospheric pollutants, etc.). Through a series of cell lysis and extraction steps, the purified bacterial material of a given volunteer is obtained.

The bacterial material in each sample is then amplified by PCR in order first to increase the quantity of DNA, and second to label the genetic material in each sample - which will later allow the identification of each sample during the sequencing step. The samples’ concentrations are levelled out prior to pooling, to give the sequencing mix. This solution is then loaded in a cartridge and analysed by a sequencer. At the end of the metagenomic analysis run, the raw files are analysed by means of various dedicated software, and the results compiled according to the client’s requirements.

Analysis performed at T0/T8.

Title

Additional specific study

An additional clinical study was conducted to measure the reduction of the number and appearance of acne lesions, and the normalization of the presence of sebum on the skin.

Clinical evaluation of skin complexion evenness and skin inflammatory status of the area interested by acne lesions, clinical evaluation of active acne lesions (inflammatory lesions) and comedones (non-inflammatory lesions), non-invasive bioengineering techniques that allow to evaluate skin moisturization, pH and sebum content.

This additional study aims to explore the synergistic impact of using The Skin Biotic nutraceutical in combination with The Gentle Cleanser compared to a topical product available on the market that is specifically formulated for acne treatment.

Subjects

Participant subjects: 80 female and male subjects aged between 18 and 50 years old (n=20 subjects for each group according to a previously predisposed randomization list) showing acne severity from 1 to 3 according to IGA (Investigator’s Global Assessment) severity scale.

The study foresaw 56 days of products use. Instrumental evaluations of the skin parameters under study were carried out at baseline and after 28 days and 56 days of products use.

Measured Parameters

Parameters below reported are assessed under controlled ambient conditions (T = 22±2°C and RH = 40-60%). Subjects are left to acclimatize to ambient condition for 15-20 minutes before the check visit.

Evaluation of skin sebum

The sebum measurement is based on the internationally recognized Sebumeter® method (Sebumeter 815, Courage+Khazaka GmbH). The measurement principle is the photometric method, the grease spot photometer. According to this method the sebum on skin is collected on a 64 mm2 mat synthetic tape contained in a cassette, then the measuring head of the cassette is inserted into the aperture of the device, where a photocell measures the transparency. The light transmission represents the sebum content on the surface of the measuring area. A microprocessor calculates the result, which is shown on the display in µg sebum/cm² of the skin.

Evaluation of skin moisturization
The measurement of skin moisturisation is based on the Corneometer® method. Corneometer® method is based on the dielectric constant of water. The probe shows changes of capacitance according to the moisture content of the skin. An electric scatter field penetrates the very first layers of the skin (10 -20 µm) and determines the dielectricity. The used device is the Corneometer® CM 825 (Courage+Khazaka, electronic GmbH).

Evaluation of skin pH
The used instrument is the SKIN pH-METER 905®, Courage + Khazaka GmbH. The measure is based on a combined electrode of high quality, in which both the glass electrode sensitive to H+ and the additional reference electrode are placed in the same site. It is connected to an handle probe containing the measurement electronics.
Before the measurements, the SKIN pH-meter® 905 (Courage + Khazaka electronic GmbH) is calibrated using two buffer solutions with known pH (pH 4.01 and 1.7) as reference.
Measurement range: 0 to 12 Accuracy: ±0.1pH

Evaluation of the number of acne lesions
The investigator visually assesses (and by palpation if necessary) the facial skin counting the acne lesions. The assessment is mainly based on the evaluation of the number of papules, pustoles, open comedones (blackheads) and closed comedones (whiteheads) on the face of the subjects.

Evaluation of skin complexion evenness
Clinical evaluation of skin complexion evenness is performed by the Dermatologist according to clinical scores ranging from 1 to 4.

Evaluation of the improvement of the skin inflammatory status
The effect of the product on the improvement of the skin inflammatory status of the area interested by acne lesions is evaluated on the digital pictures acquired in standard conditions with cross-polarized filters. The images are evaluated by the Dermatologist according to a score from 1 to 4 by comparing the images acquired at T0 with those acquired at each following time.

Digital macrophotography
Digital pictures of the face are acquired at each experimental time using a reflex digital camera (NIKON D300 digital camera, Nikon Corporation Tokyo, Japan) equipped with macro-objective (AF-S Micro NIKKOR 60mm f/2.8G ED, Nikon Corporation Tokyo, Japan), a flash system (Kit R1C1, Nikon Corporation Tokyo, Japan) and cross-/parallel-polarized filters.

Results

BEFORE

AFTER

Clinically proven results

Acne clinical signs improvement

75% skin complexion eveness improvement 1

Target: 21 years old subject / IGA Scale III
Protocol: exclusive use of The Skin Method over an 8-week period

Pictures in T0 (clinical study start) and T8 (after 8 weeks)

Notes:

1. Efficacy clinical study performed by Complife Group, a multi-certified third party providing microbiological and chemical-physical testing. All the study procedures are carried out in compliance with the ethical principles for the medical research (Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amendments).

Aim of the study

We have substantiated our dermatological safety claims through 48 hours closed human patch tests1 under occlusion to evaluate potential skin irritation after contact with the products.

This study assesses the potential side effects (skin erythema, oedema, or other types of skin irritation) that may occur after applying the tested topical products—The Gentle Cleanser, The Power Serum, The Active Cream—to evaluate whether they are safe for consumer use.

The tested cosmetic product complies with Regulation (EC) No 1223/2009 on cosmetic products and its annexes.

Subjects

25 volunteers were recruited to take a part in the test in accordance with specific inclusion2 and non-inclusion3 criteria.

Participants are withdrawn if they do not follow the conditions of the Study Information Sheet that they receive after the recruitment or if they suffer any illness or accident or develop any condition during the study which could affect the outcome of the study.

Through patch application and 24 hours after patch removal volunteers must avoid situations or activity that could interfere with clinical evaluations:

→ Exposition to sun or solarium.
→ Sport activity.
→ Immersion in water or steam bath.
→ Chafing and mechanical or thermal stress in the area in which patch is/has been applied.

Sample preparation and application

The product is applied as it is by using the Finn Chamber, an 8 mm diameter aluminium disk.

The Finn Chamber is fixed to the skin with a tape already been tested for its safety that ensure the occlusive application of the product. Applied quantity is sufficient to fill the chamber without overflowing from it when applied on the skin. The product is left in contact with the skin surface for 48 hours. The cutaneous reactions are analysed at 15 minutes, one hour and 24 hours after Finn Chamber removal.

A Finn Chamber containing a blotting paper disk soaked with demineralized water is applied and used as a negative control.

Clinical examination and scoring

Skin reactions, such as erythema, oedema, or other types of skin irritation, are evaluated at 15 minutes, 1 hour, and 24 hours after patch removal. With an IIM (Mean Irritation Index, according to the amended Draize classification from 0 to 8) ranging from 0.00 to 0.32, all the three tested product can be considered suitable for sensitive skin.

15 minutes, one hour and 24 hours after Finn Chamber removal. A Finn Chamber containing a blotting paper disk soaked with demineralized water is applied and used as a negative control.

The skin biotic analysis

Production and Analysis Protocol

To ensure product quality, AWvi R&D begins by producing a pilot batch to assess industrial scalability and monitor product stability over time. Production then occurs in environments with optimal, controlled conditions, specifically maintaining temperature below 25°C (77°F) and humidity levels between 21-23%, to preserve the probiotics' viability and guarantee the finished product's shelf life.

Furthermore, every batch produced undergoes rigorous analysis and inspection by Micro S.r.l., a specialized laboratory with external certification.

This lab operates under a Quality System compliant with the UNI CEI EN ISO/IEC 17025 standard and boasts accreditation from ACCREDIA (ILAC-MRA). Additionally, it is listed in the Lombardy Region as an officially authorized laboratory for conducting analyses in accordance with food industry self-monitoring procedures (HACCP).

Analysis Parameters and Requirements

Analysing each production batch according to the specified parameters and requirements enables us to ensure the product's efficacy and safety, while also certifying it is free from substances that may trigger sensitivities or intolerances, such as lactose and gluten.

Notes:

1. Safety dermatological study performed by Complife Group, a multi-certified third party providing microbiological and chemical-physical testing.

2. Inclusion criteria: Healthy female and male subjects; Subjects between 18 and 70 years old; Subjects informed about test purposes.
3. Non-inclusion criteria: Subjects who do not fit the inclusion criteria; Pregnant or breastfeeding women; Subjects with marks (for example tattoos, scars, burns) in the tested skin region, which might interfere with clinical evaluation; Subjects with dermatological problems in the test area; Subjects with medication that may affect skin response; Subjects undergoing pharmacological treatment (both locally or systemically); Subjects with history for contact dermatitis; Positive anamnesis for atopy.

Three-month compatibility and stability tests tracking pH and density across three temperature conditions.