Seborrhoeic dermatitis clinical trials including management of clinical studies to determine the efficacy and safety of novel treatments
Clinical studies for seborrhoeic dermatitis treatments are key to determining if a novel product significantly reduces the severity of seborrheic dermatitis and therefore establish the efficacy of treatment. Seborrheic dermatitis, (also known as seborrhoeic eczema) is a common chronic inflammatory skin disorder which affects specific areas of the skin such as the scalp.
It is believed to be a result of interaction between overproduction of sebum and Malassezia yeast species, which exists naturally in the body. Patients of all ages can be affected, from infants to elderly persons, with certain populations more susceptible to developing the disease than others.
Seborrhoeic dermatitis is typically managed with treatments that reduce the level of skin yeast – these include creams and shampoo. Dermatology trials are needed to test innovative product formulations to establish if they are safe to use on a long-term basis whilst being effective and well tolerated.
These studies must be objective and meet strict clinical controls, underpinned by robust primary outcome measurements that are relevant to seborrhoeic dermatitis clinical trials.
Seborrhoeic Dermatitis Clinical Trial Solutions
We provide investigator site services, patient recruitment solutions and management of seborrhoeic dermatitis clinical trials to determine the efficacy and safety of novel treatments. We can provide a complete service including planning, patient recruitment clinical protocol design, study management and monitoring, dermatological assessment, collection of relevant data and reporting to meet your objectives. To meet regulatory authority’s recommendations we can run randomized, blinded, multi-center studies with suitable comparator arms, which usually include a vehicle or placebo control.
Our clinical trial database of pre-qualified participants allows us to select volunteers who have a history of seborrhoeic dermatitis. Our trial management team ensures that participants comply with study restrictions, in particular, refraining from using other treatments or any topical products during the test period.
Intertek dermatologists are the assessors of clinical outcomes for symptoms and healing time relevant to seborrhoeic dermatitis. We provide an assessment of the symptoms of severity such as erythema, scaling, pruritus and burning with measurement of the duration of the maintenance of complete or almost complete clinical remission obtained after the initial treatment. 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.
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.
Our dermatology clinical trial experience for seborrhoeic dermatitis treatments ensures that you will benefit from rapid, highly credible clinical trial data that will support your decision making process and accelerate your product development.