Gabriella Santa Lucia, MD, MSCR

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Topical lovastatin 2% cream by itself was as safe and efficacious in treating disseminated superficial actinic porokeratosis (DSAP) as was the more commonly-studied lovastatin-cholesterol cream, new findings suggest.¹

DSAP—an inherited or sporadic disorder of keratinization causing dry, scaly patches—is associated with germline variations, and there is not an effective standard of care for the condition.

This research had been conducted to compare the efficacy of topical lovastatin cream to a combination of lovastatin 2% cream and cholesterol 2% (lovastatin-cholesterol cream), the latter of which had shown some promise in prior research.²

The study also aimed to examine the role of cholesterol in improving lesion clearance for DSAP, as well as to look into demographic factors and barriers to care among DSAP patients. It was authored by Gabriella Santa Lucia, MD, MSCR, of Medical University of South Carolina.

“In this study, we sought to elucidate basic demographic characteristics, current treatment regimens, and medical comorbidities associated with DSAP, the most common porokeratosis variant,” Santa Lucia and colleagues wrote.

Background and Findings

The investigators conducted a patient-blinded and assessor-blinded, randomized clinical trial at the Medical University of South Carolina in the period between August of 2020 and April of 2021. They allowed adults with a prior diagnosis of DSAP and who were not pregnant to be eligible.

The team randomized the patients to once- or twice-per-day treatment with either lovastatin-cholesterol cream or lovastatin cream to regions of the body that were symptomatic for a total of 12 weeks.

During this 12-week evaluation period, the primary efficacy measure decided upon was the treatments’ impacts on DSAP, assessed through the use of the DSAP General Assessment Severity Index (DSAP-GASI). The index is scored from 0 to 4, with 0 representing clear and 4 representing severe.

Along with the primary measure, both treatments’ effectiveness were also examined through secondary measures, including patient-reported outcomes, application frequency, and adverse events.

Of the 87 study participants, 32 were enrolled in the treatment. Lovastatin-cholesterol was given to 17 of the patients and lovastatin was given to 14 of the patients. Disease severity was found to have reduced substantially in both study arms after 12 weeks of treatment.

The investigators reported that the lovastatin-cholesterol arm showed a 50.0% reduction in disease severity, and the lovastatin arm showed a 51.4% reduction, indicating that the benefit of adding cholesterol to the treatment is not obvious.

Furthermore, adverse events were reported by a few patients, including myalgia, elevation in creatine kinase levels, application discomfort, and rash. That being said, no serious adverse events were reported, and all participants were able to finish the study.

“This preliminary study provides a signal of effect to power future subsequent studies,” they wrote. “A larger, longer-term, in-person clinical trial with a validated assessment scale may benefit this patient population.”

References

1. ^{Santa Lucia G, Snyder A, Lateef A, et al. Safety and Efficacy of Topical Lovastatin Plus Cholesterol Cream vs Topical Lovastatin Cream Alone for the Treatment of Disseminated Superficial Actinic Porokeratosis: A Randomized Clinical Trial. JAMA Dermatol. Published online March 22, 2023. doi:10.1001/jamadermatol.2023.0205.}
2. ^{Atzmony L, Lim YH, Hamilton C, et al. Topical cholesterol/lovastatin for the treatment of porokeratosis: a pathogenesis-directed therapy. J Am Acad Dermatol. 2020;82(1):123-131. doi:10.1016/j.jaad.2019.08.043.}