Challenges in the Treatment of Acne in the United States

Vol. 34. No. 5


The effective treatment of most patients with mild-to
moderate acne vulgaris is readily accomplished using
evidenced-based guidelines. At a recent clinical roundtable—
from which this educational supplement was
derived—the faculty reviewed the most current acne treatment
guidelines, the mechanisms of action of topical and systemic
medications, the burden of acne, and strategies and techniques
to promote adherence with therapeutic regimens. We offer two
articles as succinct updates on these topics.1,2
However, we devoted most of our time at that meeting to
discussing three important topics that we believe need special
attention in acne care: dilution of the term “severe acne” to the
point at which a new term is needed to describe “isotretinoinworthy”
acne; understanding and preventing scarring3; and—
given the advances in understanding acne pathophysiology—
how and when isotretinoin should be used and into which
category this medication should be placed.4
Introduced in 1982 as an “oral retinoid,” isotretinoin rapidly
became the most effective treatment available for acne; it
remains so today. However, with advances in our understanding
of acne pathophysiology has come new insights about how
isotretinoin works. Its classification as an oral retinoid does not
begin to describe isotretinoin’s mechanism of action, much as
aspirin’s categorization as a “pain reliever” does not do justice
to this drug. Furthermore, the classification of isotretinoin
as, simply, an oral retinoid has caused confusion among some
treatment stakeholders—including clinicians, pharmacists,
insurance providers, parents, and patients—who have assumed
that isotretinoin is merely an oral form of medications such as
topical adapalene, tazarotene, or tretinoin. This is a misperception
that must be corrected, especially because this inaccurate
view can result in barriers to the timely initiation of isotretinoin
therapy in patients who would benefit from its use. As we
discuss in the article “Isotretinoin: Mechanism of Action and
Patient Selection,”4 isotretinoin’s mechanism of action in acne
indicates the need for a more accurate subclassification under
the retinoid umbrella. We propose “sebocyte modulator” as a
more accurate descriptor.
We have recently seen an upsurge in topical medications
and non-isotretinoin oral medications that have been approved
by the US Food and Drug Administration for “severe acne.”
However, patients with a large number of nodules were
expressly excluded from clinical trials of these medications
and it is precisely this clinical presentation that makes patients
isotretinoin-worthy. Therefore, what are we to call isotretinoinworthy
acne? We propose that new terminology is needed. We
are concerned that the absence of a more specific term increases
the likelihood of step edits, complicating the task of acquiring
isotretinoin in a timely way for appropriate patients.
Finally, the prevailing notion for many years was that only
patients with severe acne were at risk for scarring and the
current labeling for isotretinoin reflects this view: isotretinoin
is indicated for patients with resistant scarring nodular acne.
However, some patients with less severe acne are at risk for
significant emotional scarring, and evidence shows that physical
scars can develop in patients in whom inflammation is relatively
mild. Studies also show that time to initiation of treatment is
an important factor in whether a susceptible patient develops
scars: the longer the delay in instituting effective treatment, the
greater the risk for scarring and its potentially profound, lifelong
consequences. The stakes are high for patients who can
benefit from isotretinoin. Emotional and physical scarring is
common and has been shown to worsen with delay in treatment.
If patients need isotretinoin, they should experience no barriers
to its acquisition.