Cold Sore Treatment Clinical Trial solutions including full study management assessment of clinical outcomes for Herpes simplex labialis (HSL)
Cold sore treatment (topical or systemic) clinical studies are required to examine the safety and performance of these medicines and medical devices. Cold sores are caused by the herpes simplex virus (HSV), primarily an HSV type 1 infection of the lips and perioral skin known as Herpes simplex labialis (HSL). Several factors can trigger an episode of cold sores, including emotional stress, tiredness or feeling run down, menstruation, strong sunlight exposure on the lips, an injury to the mouth or a dental procedure, and fever. For many people, however, the trigger is unknown. Cold sores usually resolve on their own without treatment in 7-10 days, but treatments may be used to help reduce the duration and severity of symptoms.
Cold sore treatment clinical trial recruitment can present a challenge for volunteer selection and participant compliance with study restrictions. The studies must be objective and meet strict clinical controls, underpinned by robust primary outcome measurements that are relevant to Herpes simplex labialis.
Clinical Trial Solutions for Cold Sore Treatments
We provide patient recruitment solutions and management of herpes simplex virus clinical trials to determine the efficacy and safety of novel treatments for cold sores. We can provide investigator site services 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 Herpes Labialis and who suffer from cold sores with the frequency defined in the trial protocol. We can recruit, based on history, participants who are likely to experience a cold sore outbreak within next two to three months to meet your trial timeline requirements. Our trial management team ensures that participants comply study restrictions, in particular, refraining from using other treatments or any topical products (lip balm, cosmetics, sunscreen) during the test period.
Our examiners are experienced in the assessment of symptoms and healing time in relation to cold sores. 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 provide an assessment of the overall condition of cold sore taking into account the size, physical impression of the lesion and overall quality of healing. Our clinicians can also offer robust scoring on the severity of erythema, edema, vesicles and scab/crust. Through a number of research partners, Intertek provides supporting virology services to complement our clinical research.
With a flexible approach to clinical delivery we can deploy demanding protocols for colds sore studies which allow subjects randomized to treatment with instruction to initiate the therapy within narrow windows.
We possess strengths in the safety assessment of topically applied treatments, and as such 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 cold sore 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.