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

June 2021 | Volume 20 | Issue 6 | Original Article | 648 | Copyright © June 2021

Published online May 21, 2021

Keshav Patel MS,a Katherine Baquerizo Nole MD,b Alan Fleischer Jr. MDb

aWestern Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI
bUniversity of Cincinnati Dermatology Department, Cincinnati, OH

Background: 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.
Objective: To determine the likelihood of achieving real world treatment success in patients with acne according to FDA guidance.
Methods: 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.
Results: 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.
Limitations: 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.
Conclusions: 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


Acne vulgaris is a common inflammatory skin condition that affects approximately 85% of teenagers at some point in their lives and up to 20% may develop facial scarring.1,2 Although acne primarily affects younger individuals, acne can persist into adulthood and can affect any age group. Acne can lead to severe scarring and psychological distress leading to lower self-esteem, anxiety, and depression.3 There are many different treatments for acne and many providers will choose a treatment regimen based on the clinical type (comedonal, papulopustular, mixed, or nodular) and severity.1

There are many different scales for grading acne severity. FDA recommends grading acne via an IGA scale. The different grades include clear (grade 0), almost clear (grade 1), mild severity (grade 2), moderate severity (grade 3), and severe (grade 4).4 The FDA suggests 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.4

The purpose of this study is to determine the likelihood of success in patients with acne according to FDA guidance. Since first-line treatment for acne can include combination therapy, we will also determine the number of medications prescribed in acne outpatient visits.


Clear or Almost Clear Rate for Medications in Acne
In this retrospective study, we relied on the FDA highlights of prescribing information to obtain the IGA 0/1 for all of the topical medications and two of the oral medications, sarecycline and drospirenone-ethinyl estradiol. For the remaining oral medications, we searched peer-reviewed publications to obtain the clear or almost clear rate. If there were multiple studies for a medication, we calculated an appropriate weighted estimate. All of the studies identified 12 weeks, except for the isotretinoin studies, which lasted 20 weeks and the drospirenone-ethinyl estradiol studies, which lasted 24 weeks.

The FDA suggests grading acne outcomes via an IGA scale, however, a few of the studies included other scoring scales such as the Evaluator’s Global Severity (EGS) or the Global Acne Assessment Score (GAAS). For the purposes of this paper, we can assume that the other scoring scales were equivalent to the