INTRODUCTION
Acne is one of the most common skin conditions affecting millions of people worldwide. There are considerable negative effects of acne including lifelong scarring, feelings of low self-esteem, and an impaired quality of life.
Acne often requires treatment with combinations of drugs, many of which are expensive. Billions of US healthcare dollars are spent annually on the treatment of acne, both for office visits and for over the counter and prescription drugs, with little to no ability to estimate their comparative benefits. In this era of ever-changing paradigms in health care delivery, it is essential that health care providers base treatment decisions on data generated through evidence-based analyses.
The lack of standardization in how acne is assessed in clinical trials makes it difficult to pool data from different trials to assess comparable efficacy of different types of treatment. Health care providers need these data to guide treatment recommendations for patients with acne.
The Acne Core Outcomes Research Network (ACORN) was formed by an international group of experts with interest in improving how acne and its impacts are measured. The goal of the ACORN group is to develop a “toolbox†of validated measures to assess acne that can be adopted by researchers conducting clinical trials worldwide.1 The use of these standardized outcome measures would generate data that could be used to conduct meta-analyses to assess comparative to help guide treatment selection.
The primary end points of regulatory clinical trials for acne are acne lesion counts and the Investigator’s Global Assessment (IGA) of acne severity. However, both lesion counting and grading approaches have not been standardized. Furthermore, maintaining consistency within and across studies is challenging due to evaluators’ subjectivity. The Food and Drug Administration (FDA) recommends that study sponsors discuss their IGA scales and study designs with the FDA before trial implementation.2 Most IGA scales use phrases such as “noneâ€, “fewâ€, “severalâ€, “moderate†or “many†inflammatory/non-inflammatory lesions as severity grade descriptors. Some scales also look at the lesion distribution using area of involvement description as “less than halfâ€, “more than halfâ€, or “entire areaâ€. A study reported that dermatologists tend to
Acne often requires treatment with combinations of drugs, many of which are expensive. Billions of US healthcare dollars are spent annually on the treatment of acne, both for office visits and for over the counter and prescription drugs, with little to no ability to estimate their comparative benefits. In this era of ever-changing paradigms in health care delivery, it is essential that health care providers base treatment decisions on data generated through evidence-based analyses.
The lack of standardization in how acne is assessed in clinical trials makes it difficult to pool data from different trials to assess comparable efficacy of different types of treatment. Health care providers need these data to guide treatment recommendations for patients with acne.
The Acne Core Outcomes Research Network (ACORN) was formed by an international group of experts with interest in improving how acne and its impacts are measured. The goal of the ACORN group is to develop a “toolbox†of validated measures to assess acne that can be adopted by researchers conducting clinical trials worldwide.1 The use of these standardized outcome measures would generate data that could be used to conduct meta-analyses to assess comparative to help guide treatment selection.
The primary end points of regulatory clinical trials for acne are acne lesion counts and the Investigator’s Global Assessment (IGA) of acne severity. However, both lesion counting and grading approaches have not been standardized. Furthermore, maintaining consistency within and across studies is challenging due to evaluators’ subjectivity. The Food and Drug Administration (FDA) recommends that study sponsors discuss their IGA scales and study designs with the FDA before trial implementation.2 Most IGA scales use phrases such as “noneâ€, “fewâ€, “severalâ€, “moderate†or “many†inflammatory/non-inflammatory lesions as severity grade descriptors. Some scales also look at the lesion distribution using area of involvement description as “less than halfâ€, “more than halfâ€, or “entire areaâ€. A study reported that dermatologists tend to
