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Evolution of Acne Assessments and Impact on Acne Medications: An Evolving, Imperfect Paradigm

Linda Stein Gold, Jerry Tan, Leon Kircik

    Journal of Drugs in Dermatology : JDD
    |January 8, 2016
    PubMed
    Abstract

    Insights

    Standardizing investigator global assessments (IGA) and success definitions in acne clinical trials is crucial. This harmonization will improve treatment comparisons and patient care by clarifying outcomes for acne medications.

    Area of Science:

    • Dermatology
    • Clinical Trials
    • Regulatory Science

    Background:

    • Acne interventional trial success is typically measured by changes in lesion counts and investigator global assessments (IGA).
    • Existing outcome measures include statistically significant differences between treatment arms and categorical improvements defined by IGA thresholds.

    Purpose of the Study:

    • To evaluate variations in outcome measures and success definitions within acne clinical trials.
    • To assess the impact of these variations on Food and Drug Administration (FDA) approval and medication indications.

    Main Methods:

    • A comprehensive review of published acne clinical trial literature was conducted.
    • Prescribing information for currently approved acne medications in the United States was analyzed.
    • Relevant regulatory guidelines were examined.

    Main Results:

    • Multiple investigator global assessment (IGA) scales exist, differing in their specific categorical definitions.
    • Definitions of overall success in trials exhibit considerable variation.
    • Outcome success metrics are not consistently translated into precise terminology for medication indications.

    Conclusions:

    • Discrepancies in IGA scales and success definitions hinder the comparison of acne treatment trial results.
    • Standardization of these elements is essential for facilitating meta-analyses and informed patient treatment selection.
    • Outcome measure success has not been uniformly integrated into acne medication indications.

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