Acne Vulgaris: The Majority of Patients Do Not Achieve Success According to FDA Guidance

The Food and Drug Administration (FDA) recommends grading Acne vulgaris via an Investigator’s Global Assessment (IGA) scale and assessing treatment as either success or failure, with success defined as clear (grade 0) or almost clear (grade 1) with at least a two-grade improvement in acne severity from baseline.

To determine the likelihood of achieving real world treatment success in patients with acne according to FDA guidance.

We calculated estimated appropriates to obtain the IGA 0/1 (clear or almost clear rate) for many of the oral and topical medications. We also used the National Ambulatory Medical Care Survey (NAMCS) data to determine the number of medications prescribed for outpatient visits when isotretinoin was prescribed or when isotretinoin was not prescribed and the one and only diagnosis was acne.

Isotretinoin had the highest IGA 0/1 at 87%. None of the other medications had an IGA 0/1 > 40%. Of all outpatient acne visits, only 6% receive isotretinoin. When excluding isotretinoin visits, 71% of patients received ≤ 2 medications.

The majority of the acne medication studies lasted 12 weeks, however, it can take 6 months or longer to get the maximum effect. None of the studies combined topical and oral medications.

The majority of acne patients are not likely to achieve success according to FDA guidance. We propose that the FDA guidance may be too rigorous. An alternative hypothesis is that most acne patients are undertreated. J Drugs Dermatol. 2021;20(6):648-651. doi:10.36849/JDD.5727.