Efficacy and Safety of Topical Nitric Oxide−Releasing Berdazimer Gel in Patients With Molluscum Contagiosum

Browning, John; Enloe, Carolyn; Cartwright, Martina; Hebert, Adelaide A.; Paller, Amy S.; Hébert, David; Kowalewski, Elaine Kearney; Maeda-Chubachi, Tomoko

doi:10.1001/jamadermatol.2022.2721

Cited by 15 publications

(19 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These results highlight the importance of lesion count reductions to patients with MC and caregivers, even when complete clearance is not achieved. The PED indicated that nearly 40% of B-SIMPLE4 participants who received berdazimer gel, 10.3% perceived complete clearance by week 12, indicating that some may have perceived lesion resolution at week 12 as complete clearance even when the complete clearance rate was 34% based on investigator lesion counts in the primary study [ 9 ]. In addition, some patients who participated in the exit interview may have achieved complete clearance at the time of the interview, which occurred 2–4 weeks after the week 12 visit.…”

Section: Discussionmentioning

confidence: 99%

“…Because the B-SIMPLE4 study was designed to fulfill regulatory requirements for marketing authorization, the exit interviews conducted as a substudy may not be an optimal setting to fully capture experiences of a wide range of patients with MC. All exit interview patients were white as the majority of B-SIMPLE4 patients were white [ 9 ]; therefore, results may not be generalizable to the general population of patients with MC. In addition, most exit interview participants were caregivers, and therefore the patient experience was primarily reported by caregivers.…”

Section: Discussionmentioning

confidence: 99%

“…Briefly, B-SIMPLE4 was a multicenter, double-blind, vehicle-controlled, parallel-group (1:1) randomized clinical trial of the efficacy and safety of berdazimer gel, 10.3% applied topically once daily for 12 weeks [ 9 ]. The study methodology, eligibility criteria, patient disposition, and efficacy and safety results for B-SIMPLE4 have been published [ 9 ]. For the PED, B-SIMPLE4 included participant and investigator perceptions of MC lesion clearance at baseline and weeks 12 and 24.…”

Section: Methodsmentioning

confidence: 99%

“…Berdazimer gel, 10.3% (SB206) is a novel, topical, nitric oxide-releasing agent under investigation as a first-in-class therapy for the treatment of MC [9][10][11][12]. The Berdazimer Sodium In Molluscum Patients with Lesions (B-SIMPLE4) pivotal phase III trial of berdazimer gel, 10.3% (Clinical-Trials.gov identifier: NCT04535531) enrolled the largestever cohort of patients with MC in a clinical trial (N = 891) with the results showing favorable efficacy and tolerability [9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results

Browning

Cartwright²,

Thorla³

et al. 2022

Am J Clin Dermatol

Self Cite

View full text Add to dashboard Cite

Background Molluscum contagiosum is often characterized by persistent lesions and bothersome symptomology. What patients with molluscum contagiosum and/or caregivers consider to be meaningful measures of therapeutic success is unknown. Objective We aimed to collect patient experience data and assess Global Impression of Change from patients and/or caregivers participating in a large phase III molluscum contagiosum interventional trial. Methods The Berdazimer Sodium In Molluscum Patients with LEsions (B-SIMPLE4) phase III study enrolled 891 patients with molluscum contagiosum. Patients were randomly assigned to berdazimer gel, 10.3% or vehicle gel applied once daily for 12 weeks. Assessments of participant and investigator perceptions of complete lesion clearance were collected at weeks 12 and 24 along with Global Impression of Change scores from 1 (very much improved) to 7 (very much worse). A subset of 30 B-SIMPLE4 patients participated in the patient/caregiver experience exit interview to evaluate bothersome signs and symptoms. Results At week 12, among participants with a ≥ 75% molluscum contagiosum lesion count reduction from baseline (as assessed by investigators), 99% (373/376) reported improvement. Perceptions of complete clearance at week 12 were nearly 40% for both participant-reported and investigator-reported Global Impression of Change in berdazimer group vs 20% in the vehicle group: 82% (322/392) of participants in the berdazimer group and 60% (237/394) in the vehicle group reported their molluscum contagiosum lesions were either very much improved or much improved at week 12. Similarly, investigators scored 80% (314/393) of berdazimer and 54% (215/396) of vehicle participants as very much improved or much improved. From the exit interview, the mean duration of participant-reported molluscum contagiosum was nearly 2 years. The most frequently reported molluscum contagiosum-related signs and symptoms were itch (n = 20), scarring (n = 18), and pain (n = 13). Visibility and contagiousness of molluscum contagiosum were the most bothersome aspects to participants. The most frequently reported psychosocial impacts were self-consciousness (n = 15) and embarrassment (n = 14). Lesion clearance was an expectation of 28/30 study participants. Overall, 26/30 reported being very satisfied (n = 18) or satisfied (n = 8) with the changes in their disease over the duration of the trial; 23/30 stated that the change in lesion count was meaningful. A mean reduction of 18 lesions (76% decrease) from the baseline lesion count was reported by participants (n = 28). Although 22 of 28 had less than complete lesion clearance, 17 of 22 reported that the reduction in the number of lesions was meaningful. Conclusions Molluscum contagiosum lesion reductions, with or without complete clearance, may be considered a therapeutic "success" by the patient/caregiver. Clinical Trial Registration NCT04535531 (registered 2 September, 2020).

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results

Browning

Cartwright²,

Thorla³

et al. 2022

Am J Clin Dermatol

Self Cite

View full text Add to dashboard Cite

show abstract

“…If you feel you have obtained this copy illegally, please contact JDD immediately at support@jddonline.com JO02023 February 2023 • Volume 22 • Issue 2 H. Han, C. Smythe, F. Yousefian, et al A pivotal phase 3 study of topical berdazimer sodium, a topical nitric oxide (NO) releasing medication has shown promising results for the treatment of MC. 52 The role of NO has been well established in boosting cutaneous innate immunity and providing a wide range of antimicrobial effects. 53 Berdazimer sodium suppresses DNA proliferation of human papillomavirus (HPV) 18 in vitro, and 12% topical application was suggested to be effective and safe for treatment of genital warts.…”

Section: Figurementioning

confidence: 99%

Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review

Han¹,

Smythe²,

Yousefian³

et al. 2023

JDD

View full text Add to dashboard Cite

Background: Molluscum contagiosum (MC) is an acute infection caused by the molluscum contagiosum virus (MCV) with a worldwide incidence of approximately 8,000 cases per 100,000 individuals annually. Greater than 90% of MC cases occur in the pediatric population, and affected adults are more likely to be younger or immunocompromised. MC has minimal inflammation initially; however, a strong inflammatory response can occur during resolution of the infection, termed the beginning of the end (BOTE). MC infections may last months to years, and it is hypothesized that persistent infections may be due to suppression of immunity by MCV proteins, thus affecting MC's clinical progression. Objective: We reviewed the current proposed mechanisms of MCV immune evasion and discuss potential therapeutic options for MC treatment. Methods: A literature search was conducted using electronic databases (Pubmed, Google Scholar, Medline). Results: We compiled 18 original research articles and identified 11 proteins produced by MCV that are postulated to participate in evasion of host immunity through various molecular pathways. These proteins and/or their downstream pathways may be influenced by MC treatments in phase 3 development, including berdazimer gel 10.3% and VP-102 cantharidin, 0.7%. Conclusion: MCV is distinctive in evading immune surveillance by inhibiting or dampening several immune pathways via the production of viral proteins. The result is decreasing local inflammatory response which contributes to the prolonged survival of MCV in the epidermis. Persistent MC can be a nuisance for some patients and treatment may be desired. Currently, no treatment has been approved by the US Food and Drug Administration (FDA). Two approaches in the pipeline may affect the immune avoidance mechanisms; nevertheless, their exact mechanisms between the potential therapeutics and viral proteins remain enigmatic.

show abstract

Molluscum Contagiosum Therapeutics—New Options May Be Around the Corner

Oza

2022

JAMA Dermatol

View full text Add to dashboard Cite

It has been 200 years since Thomas Bateman first described molluscum contagiosum (MC) in 1817, and clinicians and patients are still waiting for an evidence-based, effective therapy. 1 However, during the past 2 years, large randomized clinical trials investigating therapies for MC, including a study by Dr Browning and colleagues in this issue of JAMA Dermatology, 2 have highlighted a renewed interest in filling the therapy void.For years, many children and their parents seeking evaluation and treatment for MC have been counseled to wait it out. Although MC in an otherwise healthy child is self-resolving, the average case lasts 13.5 months, and 13% of cases are not resolved within 2 years. 3 Understandably, many families look to fast-forward their child's experience with the infection.

show abstract

Efficacy and Safety of Topical Nitric Oxide−Releasing Berdazimer Gel in Patients With Molluscum Contagiosum

Cited by 15 publications

References 27 publications

A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results

A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results

Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review

Molluscum Contagiosum Therapeutics—New Options May Be Around the Corner

Contact Info

Product

Resources

About