Dermatology clinical trials for consumer healthcare, pharmaceuticals and medical devices supporting safety and efficacy performed to GCP guidelines
Dermatology clinical trials are conducted to establish the efficacy and safety of new pharmaceuticals, over-the-counter medicines or medical devices to treat medical conditions of the skin. All new dermatological medicines and medical devices require regulated clinical testing to ensure the safety and efficacy in order to achieve regulatory authority marketing approval.
Our experience in dermatology clinical trials for pharmaceutical and medical devices include protocols to assess treatments for atopic dermatitis (eczema), herpes labialis (cold sores), seborrheic dermatitis, psoriasis and acne vulgaris, across early phases of product development. With strengths in the safety assessment of topically applied treatments we design and conduct human investigator site studies working to the EU Directive 2001/20/EC (Clinical Trials Directive), the EU Directive 2005/28/EC (GCP Directive), The Medicines for Human Use (Clinical Trial) Regulations 2004 and its subsequent amendments and also the ISO 14155 Clinical Investigation of Medical Devices guidelines.
Working from a risk based approach; our clinical investigators and dermatologists apply efficient and appropriate clinical protocols and trial methodology for dermatological research applications. We also offer dermal safety studies including primary irritation, cumulative irritation and sensitisation studies. We can also provide phototoxicity and photosensitisation screening to test for irritancy and/or allergy potential following exposures to UV light.
Qualified and Calibrated Dermatological Clinicians
We conduct many clinical dermatology studies every year, which means that examiners’ assessment skills are utilised regularly. With regular, structured calibration programs we ensure consistency among and between our assessors and provide robust data to measure variability among and between our assessors which enables optimization of our clinical assessment processes.
Our Dermatology Facilities
Intertek dermatology clinical facilities comprise five sites in the UK that offer an optimal blend of practicality and flexibility. All sites have the capability to accommodate studies in different indications with high quality clinical spaces including private examination rooms, interview areas, sample preparation and dosing stations. The versatility of our sites and staff allow us to maximize project scheduling opportunities by providing equivalent facilities and skills across a variety of locations.
GCP Bioanalytical Expertise
We also offer a range of measurement techniques including visual assessments, instrumental measures and clinical image analysis or bioanalysis of tissue or fluids. Studies are underpinned by ethical tissue sampling and GLP / GCP compliant bioanalysis from our in house bioanalytical laboratory which hold a Human Tissue Licence issued by the Human Tissue Authority UK (HTA) and is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GLP (PDF 208KB) and Good Clinical Practice (GCP) compliant bioanalytical services for the evaluation of clinical samples.
Pre-Qualified Dermatology Trial Recruitment
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), skin disease (e.g. eczema, or acne).
Our dermatology clinical trial experience for medicines and medical devices ensures that you will benefit from rapid, highly credible clinical trial data supporting your decision making process accelerate your product development through scientifically credible dermatology trials.