Foot care clinical studies generating a robust evidence base for product effectiveness and safety through expert measurement and trial design
There are many cosmetic foot care products available for consumers who are more than ever aware of their foot condition. These products are marketed for use on dry skin and cracked heels, but not all of them have undergone the rigorous evaluation of a clinical trial.
Intertek’s expertise with foot care clinical trials include all major cosmetic foot conditions such as hard skin, cracked heels, nail discolouration, sweat reduction and blisters . We provide planning, clinical protocol design, study management, dermatological assessment, collection of relevant data and reporting to meet your objectives in determining the efficacy and safety of creams, lotions and devices.
We offer bespoke foot care clinical studies with many years of experience in protocol design. Typically, foot care studies involve each participant serving as his/her own control with a distribution of each product between right and left foot across the volunteer group. Investigations are undertaken in accordance with the governing principles of the Helsinki Declaration and the relevant local regulations.
Intertek’s clinical trial database of pre-qualified participants allows us to select suitable volunteers after individual participant assessments and through experienced trial management, we ensure that participants comply with study restrictions, in particular, refraining from using other treatments or any topical products during the test period.
Our dermatology team of examiners, dermatologists and podiatrists are trained in the assessment of relevant clinical outcomes such as skin hydration/moisturisation, skin thickness and hardness, skin roughness, skin softness and skin condition. With regular, structured calibration programs we ensure consistency amongst assessors and provide robust data to measure variability in clinical outcome measures among and between our assessors which enables optimization of our clinical assessment processes.
We can also deploy clinical measurement and instrumentation including controlled, reproducible photography for image capture and analysis.
Our Clinical Research Services are ISO 9001 accredited, we operate a robust quality management system (QMS) to ensure reliable and credible scientific study data. To achieve our quality objectives and to ensure continuous improvement our in-house dedicated Quality Assurance team are responsible for compliance with human testing guidelines. The data we generate is robust enough to undergo the scrutiny of the Advertising Standards Authority.
Our mission is to provide our trial participants with excellent professional care, and provide our sponsors with the highest quality research services. With Intertek Clinical Research Services as your trial partner we can accelerate your product development through scientifically credible research.
We have a strong participant recruitment resource and maintain one of Europe’s largest characterised databases of over 12,000 pre-qualified volunteers to facilitate prompt recruitment. Volunteers are characterised by a number of therapeutic areas such as skin type (based on the Fitzpatrick scale) and skin condition (e.g. dry skin).
We can also select subjects based on habits and attitudes for use in home placement tests, central location use test, consumer use and preference studies and also research discussion groups.