Dermatology clinical trial equipment supply case study

Woodley Trial Solutions supplies equipment for CHE treatment study

Total number of patients

Global sites

Flexibility

The services provided evolved throughout the trial to meet changing needs

Minimized downtime

Streamlined calibration and reduced maintenance downtime

Download as a PDF

Need equipment for your study?

Chronic hand eczema (CHE) is classified as an inflammatory disorder that persists for more than three months or occurs twice or more within a year. The condition affects hands and wrists – exhibiting periods of flare-up and remission – and is generally difficult to treat. At the moment, the only treatment options available are those approved for other skin diseases, meaning that their precise effect on CHE has not been documented. Additionally, these medicines can often not be used for the long term due to safety concerns. There is clearly a need to find a treatment that can be applied specifically to CHE, especially for paediatric patients as few studies have dealt with this clinical cohort.

This clinical trial aimed to assess how a specific topical treatment cream – applied twice a day – could affect patients experiencing moderate to severe CHE. The cream blocks signalling pathways that activate immune and inflammatory cells known to trigger CHE, and the efficacy of this treatment has been demonstrated in previous clinical trials in adults. The study focused on the 12-17 year age group and covered three time periods, including a four-week screening period, a 16-week treatment period, and a two-week safety follow-up. The effects of the treatment were assessed through physical examinations, blood tests, urinalyses, ECGs, and questionnaires.

The key challenges

Logistical

Woodley Trial Solutions supplied all the necessary equipment for this specific study – including everything from balances, centrifuges and fridges to weighing scales, height measures, and blood pressure monitors – taking full responsibility for maintenance and calibration, as well as continuous medical device certification where necessary. The downtime was minimized by keeping a stock of ready-to-be-shipped instruments, instantly replacing equipment that was sent off site for calibration or needed to be switched out. An open communication line guaranteed that any issues or changes were addressed in a timely manner, giving the client reassurance that they were in good hands.

Administrative

Woodley Trial Solutions understands the evolving nature of clinical trials and always makes it easy for clients to extend their contracts and move equipment between different sites, as well as to expand to other countries. In this specific case, Woodley Trial Solutions supported the client’s expansion from Europe to the US and Australia, providing regulatory advice and ensuring that the new sites were supplied with everything necessary for the research. This flexibility requires experienced staff and sturdy internal protocols, especially when handling several trials simultaneously.

Summary

Woodley Trial Solutions supported the study that assessed the effect of twice-daily application of a topical treatment to manage CHE. The company supplied all the necessary equipment and provided a comprehensive service – including maintenance and support – reducing downtime by keeping stock in strategic locations. Thanks to vast global experience, Woodley Trial Solutions could streamline the expansion of the trial, handing all the logistical and regulatory concerns.

_{References
1. Chronic hand eczema -UpToDate. Accessed March 17, 2023. https://www.uptodate.com/contents/chronic-hand-eczema
2. Diepgen TL, Agner T, Aberer W, et al. Management of chronic hand eczema. Contact Dermatitis. 2007;57(4):203-210. doi:10.1111/j.1600-0536.2007.01179.x}

The downtime was minimized by keeping a stock of ready-to-be-shipped instruments, instantly replacing equipment that was sent off site for calibration or needed to be switched out. An open communication line guaranteed that any issues or changes were addressed in a timely manner, giving the client reassurance that they were in good hands.

Supporting study investigating topical treatment of chronic hand eczema

Woodley Trial Solutions supplies equipment for CHE treatment study

Logistical

Administrative

Summary

More case studies