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Zelsuvmi^TM (Berdazimer) Topical Gel.

Aditya K Gupta^1,2, Avantika Mann³, Kimberly Vincent⁴

¹Division of Dermatology, Department of Medicine, University of Toronto School of Medicine, Toronto, Ontario, Canada.

|January 3, 2025

Summary

This summary is machine-generated.

Zelsuvmi (berdazimer) topical gel is a new treatment for molluscum contagiosum (MC) in patients aged one year and older. Clinical trials show berdazimer gel effectively clears MC lesions compared to a vehicle control.

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Area of Science:

Dermatology
Pharmacology
Viral Infections

Background:

Molluscum contagiosum (MC) is a common viral skin infection affecting children and adults.
Current treatment options for MC can be limited or invasive.
Zelsuvmi (berdazimer) topical gel offers a new therapeutic approach for MC management.

Purpose of the Study:

To evaluate the efficacy and safety of berdazimer topical gel for treating molluscum contagiosum.
To compare the effectiveness of berdazimer against a vehicle control in achieving complete lesion clearance.

Main Methods:

Three randomized, double-blind, vehicle-controlled Phase 3 trials were conducted.
Participants aged one year and older with MC applied berdazimer or vehicle gel once daily.
Treatment continued until complete lesion clearance or for a maximum of 12 weeks.

Main Results:

Berdazimer demonstrated statistically significant higher efficacy in achieving complete MC lesion clearance at week 12 compared to vehicle across all three trials.
Specific efficacy rates at week 12: Trial 1 (32.4% vs 19.7%), Trial 2 (30% vs 20.3%), and Trial 3 (26% vs 22%).
Adverse events were generally mild to moderate, including application site pain, dermatitis, erythema, and pruritus.

Conclusions:

Berdazimer topical gel is an effective treatment for molluscum contagiosum in patients aged one year and older.
The safety profile of berdazimer is characterized by mild to moderate application site reactions.
Zelsuvmi represents a novel and well-tolerated therapeutic option for molluscum contagiosum.