ABSTRACT
Importance: Disseminated superficial actinic porokeratosis (DSAP) is an inherited or sporadic disorder of keratinization associated with germline variations. There is no effective standard of care therapy for DSAP, but treatment with topical lovastatin combined with cholesterol cream has shown promise. Objectives: To evaluate and compare the safety and efficacy of topical lovastatin 2% plus cholesterol 2% cream (lovastatin-cholesterol) and topical lovastatin 2% cream (lovastatin) alone in adults diagnosed with DSAP. Design, Setting, and Participants: This patient- and assessor-blinded, randomized clinical 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 eligible. Data were blindly analyzed after study completion. Interventions: 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. Main Outcomes and Measures: The primary efficacy measure was 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). Treatment efficacy was based on investigator-standardized photographs provided by the participants because of the need for evaluation via telehealth during the COVID-19 pandemic. Secondary efficacy measures included patient-reported outcomes, application frequency, and adverse events (AEs). Results: Of the 87 participants screened, 32 were enrolled. One participant randomized to receive lovastatin-cholesterol did not receive the intervention, leaving 17 participants (mean [range] age, 59.2 [40-83] years; 13 females [76.5%]; all White) allocated to receive lovastatin-cholesterol treatment and 14 participants (13 female [92.9%]; mean (range) age, 53.7 [33-71] years; all White) to receive lovastatin treatment. Twelve participants in each treatment group qualified for the analysis. Disease severity decreased from week 1 to week 12 by 50.0% (from 3.08 [95% CI, 2.57-3.60] to 1.54 (95% CI, 1.04-2.05] points on the DSAP-GASI; P < .001) in the lovastatin-cholesterol group and 51.4% (from 2.92 [95% CI, 2.40-3.43] to 1.50 [95% CI, 0.99-2.01] points; P < .001) in the lovastatin group. There was no significant difference 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. Conclusions and Relevance: This randomized clinical trial found improvements in DSAP severity in both treatment groups, without serious AEs, indicating a limited benefit with the addition of cholesterol. These results suggest that lovastatin cream may be a new primary treatment option for patients diagnosed with DSAP. Trial Registration: ClinicalTrials.gov Identifier: NCT04359823.
Subject(s)
COVID-19 , Porokeratosis , Adult , Humans , Female , Middle Aged , Lovastatin/adverse effects , Porokeratosis/drug therapy , Pandemics , Treatment Outcome , Emollients/therapeutic use , CholesterolSubject(s)
Melanoma , Skin Neoplasms , Humans , Melanoma/diagnosis , Skin Neoplasms/diagnosis , SyndromeSubject(s)
Carcinoma, Basal Cell/prevention & control , Dermatitis, Atopic/drug therapy , Drug Eruptions/epidemiology , Scleroderma, Localized/complications , Skin Neoplasms/prevention & control , 2019-nCoV Vaccine mRNA-1273 , Azetidines/therapeutic use , BNT162 Vaccine , COVID-19 Vaccines/adverse effects , Carcinoma, Basal Cell/epidemiology , Drug Eruptions/immunology , Humans , Incidence , Metformin/therapeutic use , Purines/therapeutic use , Pyrazoles/therapeutic use , Registries/statistics & numerical data , Scleroderma, Localized/drug therapy , Scleroderma, Localized/immunology , Skin Neoplasms/epidemiology , Sulfonamides/therapeutic useABSTRACT
Phytophotodermatitis is a cutaneous reaction that occurs after exposure to plant-derived furocoumarins and ultraviolet A light. Psoralen is the most common phototoxic furocoumarin and is present in varying levels within many different plant species. This article focuses on the diagnosis and management of psoralen-induced phytophotodermatitis along with other clinical applications.
Subject(s)
Dermatitis, Phototoxic/etiology , Ficusin/toxicity , Furocoumarins/toxicity , Photosensitivity Disorders/etiology , Ultraviolet Rays/adverse effects , Humans , Plants, ToxicSubject(s)
Biological Products/administration & dosage , COVID-19/immunology , Cytokine Release Syndrome/prevention & control , Immunologic Factors/administration & dosage , Psoriasis/drug therapy , Biological Products/adverse effects , COVID-19/complications , COVID-19/mortality , COVID-19/transmission , Clinical Trials as Topic , Cytokine Release Syndrome/immunology , Cytokine Release Syndrome/mortality , Decision Making, Shared , Dermatology/standards , Glucocorticoids/administration & dosage , Glucocorticoids/adverse effects , Glucocorticoids/standards , Humans , Immunologic Factors/adverse effects , Immunologic Factors/standards , Practice Guidelines as Topic , Psoriasis/immunology , SARS-CoV-2/immunology , Symptom Flare UpABSTRACT
The Publisher regrets that this article is an accidental duplication of an article that has already been published, https://doi.org/10.1016/j.jaad.2020.09.005. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.