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. 2025 May;92(5):1117-1119.
doi: 10.1016/j.jaad.2025.01.015. Epub 2025 Jan 15.

Establishing minimally important difference thresholds for lesion counts in acne clinical studies

John S Barbieri  1 , Susan S Ellenberg  2 , Ann Tierney  2 , Suzette Baez VanderBeek  3 , Maryte Papadopoulos  3 , Jennifer Mason  3 , Anabel Mason  3 , James Dattilo  4 , David J Margolis  3
Affiliations

Establishing minimally important difference thresholds for lesion counts in acne clinical studies

John S Barbieri et al. J Am Acad Dermatol. 2025 May.
No abstract available

Keywords: acne; comedones; comparative effectiveness; inflammatory; minimally important change; minimally important difference; noninferiority; noninflammatory.

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Conflict of interest statement

Conflicts of interest Dr Barbieri has received consulting fees from Dexcel Pharma and Honeydew Care for work unrelated to the current submission. The remaining authors have no other conflicts to declare.

References

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    1. McGlothlin AE, Lewis RJ. Minimal Clinically Important Difference: Defining What Really Matters to Patients. JAMA. 2014;312(13):1342–1343. doi:10.1001/jama.2014.13128 - DOI - PubMed
    1. Food and Drug Administration. Non-Inferiority Clinical Trials to Establish Effectiveness: Guidance for Industry. Published online November 2016.
    1. Barbieri JS, Ellenberg S, Grice E, et al. Challenges in designing a randomized, double-blind noninferiority trial for treatment of acne: The SD-ACNE trial. Clin Trials Lond Engl. Published online July 27, 2024:17407745241265094. doi:10.1177/17407745241265094 - DOI - PMC - PubMed
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