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Background: Molluscum contagiosum (MC) is a contagious viral skin infection. Berdazimer gel, 10.3% (SB206 12%) is approved in the United States as the first topical, at-home MC prescription medication., Objective: To assess safety and tolerability of SB206 12% in Japanese patients with MC., Methods: SKN15B01 (JRCT2031230123) was a phase 2, multicenter, single-group, open-label study in Japanese patients ≥2 years old with 3-70 baseline MC lesions. Patients with only periocular MC and/or immunosuppression were excluded. SB206 12% was applied once daily to lesions for 12 weeks. Safety endpoints included adverse events and local skin reactions. Exploratory efficacy endpoints included percentage of patients with complete lesion clearance and lesion count percent change from baseline., Results: Twenty patients (12 males, 8 females) with mean (range) age of 5.2 (3-13) years and mean (range) baseline lesion counts of 22.5 (8-44). Complete clearance and percent change from baseline at week 12 were 60% and -89.2%, respectively. The most common treatment-related adverse events were application site-erythema (25%, n  = 5), -pain (25%, n  = 5), -pruritis (25%, n  = 5), and -dermatitis (20%, n  = 4), all mild/moderate in severity., Limitations: Single-group study; small sample size., Conclusion: Safety and efficacy of berdazimer gel, 10.3% in Japanese patients were favorable and consistent with previous studies., Competing Interests: Dr Kawashima has consultant arrangements with Sato Pharmaceutical Co, Ltd. Authors Tani, Kaneko, Masubuchi, Yasukawa, Sawasaki, and Okada are employees of Sato Pharmaceutical Co, Ltd. Author Enloe and Drs. Geer, Cartwright, and Maeda-Chubachi are employees of Pelthos Therapeutics., (© 2024 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.)

Molluscum contagiosum (MC) is characterized by skin lesions containing the highly contagious molluscum contagiosum poxvirus (MCV). MCV primarily infects children, with one US Food and Drug Administration (FDA)-approved drug-device treatment in use but no approved medications. Assessing antivirals is hindered by the inability of MCV to replicate in vitro. Here, we use vaccinia virus as a surrogate to provide evidence of the anti-poxvirus properties of berdazimer sodium, a new chemical entity, and the active substance in berdazimer gel, 10.3%, a nitric oxide-releasing topical in phase 3 development for the treatment of MC. We show that berdazimer sodium reduced poxvirus replication and, through a novel methodology, demonstrate that cells infected with drug-treated MCV virions have reduced early gene expression. Specifically, this is accomplished by studying the nuclear factor kappa-light-chain-enhancer of activated B cell (NF-kB)-blocking protein MC160 as an example of an early gene. The results provide a plausible unique antiviral mechanism of action supporting increased MCV resolution observed in patients treated with berdazimer gel, 10.3% and describe a novel methodology that overcomes limitations in investigating MCV response in vitro to a potential new MC topical medication.

The beginning of the end (BOTE) sign has been proposed to describe well-recognized clinical signs of inflammation (including erythema, induration, and scale) that predict imminent resolution of molluscum contagiosum (MC). This phenomenon has never been prospectively studied. An integrated analysis of two prospective, 12-week, randomized, double-blind clinical trials of topical nitric oxide-releasing SB206 gel evaluated an association between BOTE sign and MC lesion reduction. Of 707 randomized patients, ~80% exhibited BOTE signs regardless of treatment assignment. At week 12, MC lesion counts decreased from baseline by 50.7% for baseline BOTE+ versus 29.1% for BOTE- ( P  = 0.0015) vehicle-treated patients compared with a 63.3% decrease for baseline BOTE+ versus 51.7% for BOTE- ( P  = 0.0194) SB206-treated patients. Among vehicle-treated patients, 48 (22.3%) who were never BOTE+ had an 18.5% reduction from baseline in MC lesion counts versus a 34.0% reduction in 165 patients (76.7%) who experienced BOTE at any time, suggesting that the projected duration of lesion clearance for patients with 18-20 MC lesions is 15 months for BOTE- versus 6 months for BOTE+ patients. Patients who were both BOTE+ and treated with SB206 had the greatest reduction in MC lesion count. SB206 may trigger BOTE signs and shorten the duration of MC infection. The two studies whose data are analyzed in this study are registered at ClinicalTrials.gov with the identifiers NCT03927703 and NCT03927716., (© 2021 The Authors.)

Psoriasis treatment responses are affected by patient characteristics. However, the literature does not contain reviews of factors that affect the response to biologic therapies. We therefore performed a comprehensive literature search to identify papers describing demographic, lifestyle, and clinical factors associated with response to biologic drug therapy in psoriatic patients. We found that age, gender, ethnicity, alcohol consumption, smoking, geographic location, age at diagnosis, duration and severity of psoriasis, and baseline C-reactive protein levels did not consistently affect response to biologic psoriasis therapy. However, increased body mass index (BMI) appears to adversely affect responses. It might therefore be valuable to include BMI as a stratification variable in future studies of psoriasis therapies and to consider a patient's weight or BMI when selecting a systemic psoriasis treatment.