The Use of a Reliable, Ubiquitous, Inexpensive, and User-Friendly Tablet-Based System to Track Target Lesion Improvements in Subjects With Plaque Psoriasis Treated With Clobetasol Propionate 0.05% Spray

March 2015 | Volume 14 | Issue 3 | Original Article | 236 | Copyright © 2015

Thomas H. Wiser PharmD, Matthew H. Meckfessel PhD, Warren Winkelman MD PhD MBA

Galderma Laboratories, L.P., Fort Worth, TX

Abstract

Ubiquitous electronic devices, such as smartphones and tablets, have the potential to enable a fundamental shift in the paradigm of healthcare as these devices may allow patients and health care providers (HCPs) to rapidly and remotely communicate with each other. Once fully realized, these devices may facilitate interactions between patients and HCPs. While these devices hold much promise, much work remains in assessing their viability in various diseases. A pilot study was conducted to investigate the use of a tablet-based numeric rating scale to assess improvements in a plaque psoriasis target lesion treated with clobetasol propionate 0.05% spray (CPS). Twenty-eight subjects with plaque psoriasis enrolled and were treated with CPS twice daily for 15 days. Target lesion severity (scale of 0 [no psoriasis] to 10 [very severe psoriasis]) and effectiveness scores (scale of 0 [none] to 3 [severe]) were recorded using a tablet-based system by the investigator and subjects. The tablet was also used to take photos of the target lesion to capture photographic evidence of improvement. Investigator and subject assessed target lesion severity and effectiveness scores improved during the study from baseline to day 15; in addition subjects indicated a high level of satisfaction with CPS treatment. Very few technological failures were reported and captured photographs were consistent visit to visit and of high quality. Taken together, this study supports the use of a tablet-based system to measure and track plaque psoriasis disease progression and also confirmed that CPS is an effective and safe treatment for plaque psoriasis.

J Drugs Dermatol. 2015;14(3):236-241.

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INTRODUCTION

Can modern, simple, and ubiquitous information and communication technologies (ICTs), such as smartphones and tablets, be useful conduits in physician-patient discourse? ICTs are accepted by patients and physicians for reasons of convenience, cost, promoting patient empowerment, and the potential for augmenting adherence. However, rapid acceptance of such “new and cool” technologies begets asking a fundamental clinical question: do patients and dermatologists “see” the same thing when communicating about that individual patient’s own personal skin disease? An individual’s health literacy, disease severity, past experiences, and underlying emotional or psychosocial factors may influence how patients feel about their disease and, therefore, affect how they communicate about symptoms with their dermatologists.

A pilot exploratory study was conducted to investigate the use of a simplified, patient-friendly tablet-based numeric rating scale to assess investigator- and subject-assessed improvements in signs and symptoms of a plaque psoriasis target lesion under treatment with clobetasol propionate 0.05% spray (CPS). Topical corticosteroids are the foundation of treatment for the majority of patients as most respond effectively and safely to topical corticosteroids.1 CPS has demonstrated efficacy and safety in clinical trials comprising over 2,200 subjects.2,3 The well documented and accepted known clinical response to CPS made it a suitable choice to investigate the use of a new ICT tool.

METHODS

This was a prospective, open-label, single arm, single-site clinical study. Men and women who were at least 18 years old with a diagnosis of moderate to severe plaque psoriasis affecting up to 20% of the body surface area (BSA) were eligible for enrollment. Subjects who were on medications for their plaque psoriasis, including biologics, were allowed to enroll.

Subjects applied CPS to a target lesion measuring at least 1cm x 1cm twice daily for 2 weeks. Subjects were allowed to apply study drug to non-target lesions as well. Subjects who were on concomitant topical medications were allowed to apply their current treatment on other lesions; only CPS was applied to the target lesion.

This study was not powered and did not have a primary efficacy endpoint. The assessment scales and tablet application used

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