Biophysical, Objective, Percentage-Based Laboratory Instrumental Assessments
At Validated Claim Support, we know that Biophysical Instrumentation is critical when it comes to demonstrating what your product is capable of when it comes into contact with the skin. There is nothing stronger in skincare and personal care product testing than a straight forward percentage based improvement in the skin’s measurable condition. User Trials and Questionnaires have a time and a place, but an FDA Registered and Inspected Clinical Laboratory with temperature and humidity controls and a custom built research facility will provide a completely different level of claim support.
Clinical Grade Instruments For Your Next Consumer Study
Percentage-based improvements can be utilized in Consumer Product Testing, and are used to support a wide range of Anti Aging Claims, Active Ingredient Testing Assays, Makeup and Cosmetics, and Over The Counter products.
Instrumental claims are generally considered to be among the most robust clinical data that can be provided in skincare testing, medical device claim support, and haircare product testing.
Biophysical Instrumentation In Practice
Instrumental claims are among the most compelling data that can be provided through in-vivo clinical studies because they deal in direct percentage-based improvements or decreases.
They are excellent for directly comparing multiple products simultaneously when it comes to hydration/moisturization, barrier protection, or shine/gloss.
From a cost perspective this added value does come at a cost, as each instrument is intended only to consider one very specific endpoint such as Oil Production/Sebum, Hydration, Barrier Protection, Skin Color/Tone, etc. There is no flexibility to look at multiple parameters with a hard percentage based improvement number unless you build each instrument into the study design.
Consumer Product Testing Scale Design And Clinical Scoring
Scales are dependent on the particular instrument, and may be linear (Arbitrary Units) or logarithmic (PH).
Data is provided in percentage based improvements that can be linear or logarithmic, and also numerically based on the clinical instrument utilized.
Final data output includes both percentage based improvement as a mean based on the number of study participants, as well as the total number of subjects showing improvement for a given condition. “Maximum” improvement or reduction can also be provided as a means to support a claim such as “Up to a 85% improvement in hydration in as little as one use.”
Clinical Testing Instrumentation Supplied By The Industry Leaders
VCS’ main instrument suppliers are Courage & Khazaka, Canfield Scientific, Canon, Delfin, Nova Corp, and Konica Minolta, and AD Instruments who have provided a variety of bases and probes that can designate and record changes in underlying conditions.
VCS maintains the following devices onsite with calibration records available upon request:
- Visioscan (Courage & Khazaka): A sophisticated LED UV-A light video camera with high-resolution image capture is deployed to study the skin surface. Images demonstrate the changes in contrast and structure in the skin. Properties such as fine lines and wrinkles along with surface roughness are commonly measured via Visioscan.
- Cutometer (Courage & Khazaka): Viscoelastic property measurements of the skin are taken as a function of mechanical deformation via suction. Negative pressure is created, and skin is drawn into the aperture of the probe. The Cutometer aids specifically in skin firmness and skin elasticity claim support, which is often paired with Anti-Aging study designs.
- Corneometer (Courage & Khazaka): Measures hydration levels of the skin via dielectric properties. Useful for hydration, dry skin, and moisturization-related claims. The Corneometer is the most commonly used instrument for hydration claims in the industry and has been a staple of hydration support for 30 years.
- Epi-D Moisture Meter (Delfin): Measurement of water content at epidermal level provides important information to assist with understanding skin healthiness and the effect of products and ingredients on the skin. The MoistureMeterD introduces a practical and cost-effective way to measure deep skin hydration at the epidermal layer, not only on the skin surface.
- Colorimeter (Courage & Khazaka): Color measurements on the skin measure the absorbency of light waves by analyzing the intensity of electromagnetic radiation in the visible light region.
- Glossy-meter (Courage & Khazaka): Gloss measurement – Gloss and shine are particularly important measurements for decorative cosmetics and personal care. Reflectance is measured by assessing the portion of light reflected and mirrored from the surface.
- Tewameter (TEWL) (Courage & Khazaka): Transepidermal Water Loss – Measures the density gradient of the water evaporation from the skin indirectly via two different sensors that are calibrated to collect temperature and humidity data inside of a hollow cylinder. Tewameter is most often deployed to measure film-forming capacity and to assist with secondary moisturization claims.
- Sebumeter (Courage & Khazaka): Skin Surface Oil – A special film is applied to the surface of the skin via cartridge, and the strip is then analyzed to determine variations in film transparency via spectrophotometric measurements. The Sebumeter is most commonly used to assess surface oil reduction claims in skincare products.
- pH Meter (Hanna Instruments, Courage & Khazaka): Skin Balance and PH Claims – the pH meter is an electrical device that determines the acidity or basicity of solutions or on the surface of the skin. pH meters are calibrated with control buffer solutions that span the range of the area or substrate being measured.
- Vapometer (TEWL) (Delfin Technologies): Transepidermal Water Loss – Measures the density gradient of the water evaporation from the skin indirectly via two different sensors that are calibrated to collect temperature and humidity data inside of a hollow cylinder. Tewameter is most often deployed to measure film-forming capacity and to assist with secondary moisturization claims.
- Moisturemeter Epi-D (Delfin Technologies):The MoistureMeterD Compact is a portable and non-invasive instrument for local measurements of tissue water. It is a unique tissue water-specific instrument for assessing percentage water content (PWC) in biological tissues. It measures the tissue dielectric constant (TDC) in the skin and subcutis in seconds after applying the measurement probe on the skin. TDC values are converted into percentage water content (PWC) scale from 0 to 100 % for easy interpretation of results.
- VISIA CR: Nova Dermal Phase Meter – Utilized to attain measurements of skin surface impedance to determine individual treatment sites’ electroconductivity. This data gives a relative measure of retained water content, which is a direct function of hydration levels in the skin.
- Novameter (Nova Corporation): Nova Dermal Phase Meter – Utilized to attain measurements of skin surface impedance to determine individual treatment sites’ electroconductivity. This data gives a relative measure of retained water content, which is a direct function of hydration levels in the skin.
- Minolta Chromameter/Colorimeter (Minolta): A handheld device that is used to measure the color of objects and the skin surface. Data can be reported in L*A*B* format in order to normalize and measure consistent changes in values that are most relevant to skin tone assessments.
- Laser Doppler (AD Instruments): Fluid Velocity: Most commonly used to assess blood flow and surface-level support changes in the skin after product application or treatment. Particles are measured suspended in fluid as they pass through a fringe or interference pattern. PeriFlux Sytem 5000 is used to monitor cutaneous blood flow/perfusion. The PF 5010 – LDPM unit (laser doppler perfusion monitoring) is used for non-invasive blood perfusion measurements based on laser doppler technology. Laser doppler measures the total, local microvascular flow to follow dynamic changes in microcirculation. The measurements are given in perfusion units (PU). An increase in values represents an increase in blood flow of the skin surface.
- Dermo (Varenne Technologies): The Dermo measures both collagen and water concentration in the dermis. The device uses infrared sensors that take 500,000 measurements a second. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more collagen, the more reflectance; the more water, the less reflectance. Collagen readings range from 10 to 99 which correspond to the half of the optical scattering coefficient of the dermis. Water concentration in the dermis readings range from 40% to 85%.
- Antera 3D (Miravex): Antera 3D™ is an imaging device for the analysis and evaluation of the skin for surface topography, fine lines/wrinkles, which allows the view of skin in 2 and 3 dimensions as well as multi-spectral analysis of epidermis and dermis.
- Laser Doppler/Bloodflow Meter (ADInstruments): Antera 3D™ is an imaging device for the analysis and evaluation of the skin for surface topography, fine lines/wrinkles, which allows the view of skin in 2 and 3 dimensions as well as multi-spectral analysis of epidermis and dermis.
- AGE Scanner (Diagnoptics):The AGE Scanner developed by DiagnOptics Technologies, is an optical consumer device that uses LED light sources and light sensors to provide a measurement of the concentration of Advanced Glycation Endproducts (AGEs) in human skin tissue. The AGE Scanner is used with the myAGEnow application. AGEs are fluorescent and to capture this, the AGE Scanner shines a small amount of UV light into the skin. This light penetrates the skin and reaches the collagen underneath. This causes the AGEs that are bound to it to light up. This fluorescent signal is received by the highly sensitive sensors in the AGE Scanner and measured. The AGE scanner will output a myAGEnow score in arbitrary units (AU). The lower the score is, the “younger” the skin is.
- Ultrasound DermaScan C (Cortex):The DermaScan C USB (Cortex Technology ApS, Hadsund, Denmark) is a compact high resolution ultrasound scanner. The 20MHz, high definition 60 x 150 µm, 13 mm penetration probe provides linear scanning, high precision operation and true position detection for image clarity and definition. Ultrasound scans will be analyzed for dermal thickness.
Expert Grading Versus Instrumentation
Expert grading lets you cover a wide range of parameters at a reasonable cost point, but it does not provide the same “% improvement” numbers that instrumentation or photos do. It’s got a wider reach but less hard numerical endpoint data.
Instrumentation provides you with direct percentage based improvements such as improves hydration by up to 125% in as little as one use. Each individual parameter requires a specifically designated instrument, which comes at a cost.
Both offerings are among the most robust clinical data available for supporting skincare and personal care products through clinical studies and claim support research.
Before & After Photography
Clinically Validated, High Resolution Before and After Images and Analysis Over Time. Validated Claim Support offers cutting-edge, high-resolution photography to help document product efficacy over a given treatment timeline or product usage cycle.
