Innovative gel speeds up clearance of molluscum contagiosum lesions

A nitric oxide (NO)-releasing gel consisting of 2 components showed to be effective against molluscum contagiosum (MC). In the pivotal phase 3 B-SIMPLE4 trial, almost a third of patients achieved complete clearance of all skin lesions after 12 weeks of treatment with the berdazimer 10.3% gel.

MC is a viral infection that primarily affects children and for which no approved treatment currently exists. It is caused by a poxvirus and is characterised by small, round, firm, umbilicated, often painless bumps [1]. Although usually harmless and self-limited, possible psychosocial complications can include stigma, disfiguring lesions, and scars. In addition, MC can take a long time to resolve, ranging from 13 months to 4 years [2,3]. At present, up to 73% of children with MC go untreated [4].

NO is an endogenous small molecule (gas) with several diverse physiological, cellular, and molecular functions. It modulates many physiological functions including blood pressure control, vascular tone, and immune modulation [5]. It also has antimicrobial activity and thus may be a potential therapeutic agent for the treatment of MC. This was the rationale for Prof. John Browning (University of Texas, TX, USA) and colleagues to test a NO-releasing gel in this indication [6].

Berdazimer gel allows controlled NO release

Berdazimer 10.3% is an investigational gel that consists of 2 components: a gel containing berdazimer sodium, which is a macromolecule composed of a polysiloxane backbone with covalently bound N-diazeniumdiolate NO donors, and a hydrogel that promotes NO release.

In a late-breaker session, Prof. Browing presented the results of the multicentre, double-blind phase 3 B-SIMPLE4 trial (NCT04535531), which enrolled 891 children and adults with an MC infection [6]. Almost 90% of participants were between 2 and 12 years old. Patients or their caregivers applied berdazimer gel or vehicle for 12 weeks to raised and palpable MC lesions (baseline and new lesions). The primary study endpoint was the proportion of patients with complete clearance of all raised and palpable MC lesions at week 12.

After 12 weeks, significantly more participants treated with berdazimer gel (n=444) compared with vehicle gel achieved complete clearance of all lesions (32.4% vs 19.7%; P<0.0001; see Figure). Significant effects were seen from week 4 onwards. At 12 weeks, 43% of patients with the novel gel versus 23.9% in the vehicle group achieved a 90% MC lesion clearance (P<0.0001).

Figure: B-SIMPLE4: Complete clearance of all lesions by week 12 was greater for those receiving berdazimer 10.3% gel versus vehicle. Modified from [6]
*P=0.0121; **P=0.0014; ***P<0.0001. ITT, intention-to-treat; NRI, non-responder imputation.

The gel was generally well tolerated. The most frequent side effects were application site pain and erythema. The latter peaked at week 2 and subsided after that. Most side effects were mild in severity, and pain was primarily transient.

Prof. Browning concluded that berdazimer 10.3% gel is a first-in-class, novel, topical treatment that yields controlled release of antiviral NO upon application to the skin and likely inhibits MC viral replication with minimal pain. The innovative gel might also show potential in several other dermatological diseases.

 

1. 
   
   1. Meza-Romero R, et al. Clin Cosmet Investig Dermatol 2019;12:373–381.
   2. Olsen JR, et al. Lancet Infect Dis 2015;15:190–195.
   3. Centers for Disease Control and Prevention. Molluscum contagiosum. [Accessed on 6 April 2022].
   4. Basdag H, et al. Pediatr Dermatol 2021;32:353-357.
   5. Donald JA, et al. Handbook of Hormones (2nd Edition), Academic Press 2021:1083–1086.
   6. Browning JC, et al. Berdazimer gel 10.3% (SB206): A novel, topical nitric oxide releasing medication: results from a pivotal phase 3 study in patients (children and adults) with molluscum contagiosum. F045, AAD 2022 Annual Meeting, 25–29 March, Boston, MA, USA.

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Posted on 17 May 202223 May 2022