Safety - The Primary Endpoint in the Majority of the Clinical Trials in Dermatology

Monday 20 February 2012, Amsterdam

The report examines different aspects under clinical trial endpoints in dermatology such as analysis on major marketed drugs with an emphasis on safety and efficacy details, Phase II and Phase III clinical trial analysis for both completed and ongoing clinical trials, most promising drugs with more emphasis on safety, efficacy and clinical trial details, and terminated trial analysis. The company profiling highlights the marketed drugs in dermatology of different companies.

Safety - The Primary Endpoint in the Majority of the Clinical Trials in Dermatology

Safety is the most important endpoint in drawing conclusions on the results of a clinical trial in dermatology. Adverse events are an important safety issue in clinical trials. The adverse events associated with a drug have to be determined in terms of their frequency, severity and the time when they occur after randomization across a group of patients compared to another group. The approval system established by the Food, Drug and Cosmetics Act of 1938, required all drugs to be approved for safety by the Food and Drug Administration (FDA); failing which the trial would be discontinued/terminated and many valuable drugs would not enter the market.

Secondary Endpoints are Widely Used in the Clinical Trials of Major Dermatological Disorders

See figure: Endpoints - Clinical Trials in Dermatology, Widely Used Secondary Endpoints in Clinical Trials of Major Five Dermatological Disorders, Global, 2011

The classification of the five major dermatological disorders is based upon the number of pipeline molecules present in Phase III stage of development. Safety is the most commonly used secondary endpoint in clinical trials of AD followed by the Change in non-inflammatory lesions count which is most widely used in clinical trials of acne vulgaris. The Varicella Zoster Virus (VZV) antibody response, Clinical response and Hair growth are secondary endpoints which are most widely used in clinical trials of HZ, candidiasis and alopecia respectively.

Inflammatory Lesions Count - An Endpoint Used in Clinical Trials of Most of the Marketed Drugs in Acne Vulgaris

The major marketed drugs used to treat acne vulgaris are Solodyn, Doryx, Epiduo, Duac, Tazorac, Ziana, Differin and Benzaclin. The endpoint used in clinical trials of Solodyn, Epiduo, Duac, Tazorac, Ziana, Differin and Benzaclin was mean/absolute/percentage change in inflammatory lesions count. This was used as a major endpoint in most of the clinical trials of acne vulgaris. The inflammatory lesions count includes nodules, papules and pustules. The change in inflammatory lesions count is measured by Investigator’s Global Assessment (IGA) score. Success is defined as decrease in IGA score by at least 2  rades from the baseline score.