A new study found that there were no significant benefits in clinical improvements in Disseminated superficial actinic porokeratosis (DSAP) after adding cholesterol 2% cream to 2% lovastatin instead of plain lovastatin alone. The clinical improvements were almost similar in both groups as per the study results that were published in the journal JAMA Dermatology.
Disseminated superficial actinic porokeratosis (DSAP) is an inherited or sporadic disorder of keratinization associated with germline variations. As there is no effective standard of care therapy for DSAP, researchers conducted a patient- and assessor-blinded, randomized clinical trial to evaluate and compare the safety and efficacy of topical 2% lovastatin combined with 2% cholesterol cream and topical lovastatin alone in adults with DSAP.
The trial was conducted at the Medical University of South Carolina between August 3, 2020, and April 28, 2021. Nonpregnant adults with a previous clinical or histological diagnosis of DSAP were blindly analyzed after study completion. Participants were randomized to once- or twice-daily application of either lovastatin-cholesterol cream (n = 17) or lovastatin cream (n = 14) to symptomatic regions for 12 weeks. The effect of the treatment on DSAP at the end of treatment (12 weeks) as measured by the DSAP General Assessment Severity Index (DSAP-GASI; scored from 0-4, with 0 indicating clear and 4 indicating severe) was the primary efficacy measure. Efficacy was assessed based on investigator-standardized photographs provided by the participants during the COVID-19 pandemic. Patient-reported outcomes, application frequency, and adverse events (AEs) were the secondary efficacy measures.
Key findings:
Of the 87 participants screened, 32 were enrolled. Of the total, only 17 participants with a mean [range] age of 59.2 [40-83] years received lovastatin-cholesterol treatment, and 14 participants with a mean (range) age of 53.7 [33-71] years received lovastatin treatment. out of them, twelve participants in each treatment group qualified for the analysis. From week 1 to week 12, disease severity decreased by 50.0% in the lovastatin-cholesterol group and 51.4% in the lovastatin group.No significant difference was found between the treatment groups according to application frequency at the end of 12 weeks. Adverse events reported included myalgia (n = 2), elevation in the creatine kinase level (n = 1), application discomfort (n = 4), and rash (n = 1). No serious AEs occurred, and all participants with an AE were able to complete the study.
Thus, the addition of 2% cholesterol had only a limited benefit with no significant clinical improvements between the two groups.
Further reading: 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
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