What is it about?
There are 2 main measures for diseases activity in papulopustular rosacea (both relevant for Health Authorities, i.e. the US FDA, to register a new drug treatment for this disease). One is a complex assessment of an expert regarding disease severity, based on certain disease symptoms. The other one is easier to handle and potentially more objective: the lesion count measures the numbers of papules and pustules in rosacea. However, while a responder definition for the first measure is self-explanatory ("clear" or only "minimal" residual symptoms under treatment), the second one had no such definition. Here, we empirically define one, based on thousands of observations from patients who took part in multiple Phase II and III studies (each of those have been published earlier).
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Why is it important?
A responder definiton for the the lesion count, an objective and easy to handle endpoint, helps to define studies and contributes to easier study design, potentially smaller study sizes and thus may facilitate furtehr insight in this area.
Perspectives
I hope people doing clinical research in this disease can benefit from this definition, and by potentially making study design easier and more straight forward, I hope additional insight may be gained in the treatment of papulopustular roscacea - ultimately offering benefits for the patients that are suffering from this condition.
Kaweh Shakery
Read the Original
This page is a summary of: An empirically generated responder definition for rosacea treatment, Clinical Cosmetic and Investigational Dermatology, September 2017, Dove Medical Press,
DOI: 10.2147/ccid.s139352.
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