Molluscum is a common, highly contagious, and burdensome condition1,2
Not an actual patient.
For children, the impact of molluscum may go well beyond skin deep1,2
Molluscum is a persistent condition that results in unsightly lesions that can cause itching, discomfort, scarring, and sometimes pain.3-6
- If left untreated, lesions can expand from just a few to dozens (or more) across other parts of the body2,4,7
- Infected children may feel self-conscious about their appearance and can even be discouraged or barred from activities that involve close physical contact3,5,6
30%
of molluscum cases persisted beyond 18 months2*
For parents and caregivers, molluscum may create daily concerns beyond skin care
As molluscum progresses, parents/caregivers may worry about3,5,6:
Spreading to siblings
Child's discomfort
Repeated office visits and treatment
Missed school and/or work
Waiting for appointments
Multiple office copays
41%
of children transmitted molluscum to another child in their household2*
Preventing the spread of molluscum can be burdensome and may require modifications to daily activities to stop contamination of shared objects such as3-5:
Clothing
Towels
Bedding
Washcloths and bath sponges
Toys
Household surfaces
For healthcare providers, molluscum can be a persistent challenge3
- Molluscum is a viral skin condition that affects an estimated 16 million people in the United States overall. Each year, about 6 million new cases are diagnosed, with more than 90% occurring in children3,8-10
- There is no standard of care or treatment guideline in the United States for managing molluscum6
- A lack of well-tolerated, effective treatments that can be administered at home has led to limited options3,6
Approximately 6 million
people in the United States are newly diagnosed with molluscum each year2,10
Current molluscum management approaches may fail to meet the needs of patients/caregivers
Watch and wait
Allowing the infection to resolve on its own without medical intervention5
- In one study, 73% of children with molluscum went untreated1
- Lesions, which may last for months to years, remain contagious until resolved, prolonging discomfort and increasing the risk of spreading to themselves and others4,11
- Scratching lesions can increase the risk of spread, secondary infections, and scarring4,6,11
Procedural treatments/destructive modalities
- Cryotherapy—liquid nitrogen is applied to lesions, rapidly freezing the tissue and forming intracellular ice crystals that disrupt cell membranes. May be painful to some patients5,12
- Cantharidin—a topical agent derived from blister beetles that must be precisely applied to each lesion, typically by a healthcare provider. Some patients may experience blistering and localized pain after application3,5
- Curettage—a dermatological surgical procedure used with a topical anesthetic to physically remove each lesion. Some patients may experience pain and scarring3,5
- May not be suitable for young patients or for lesions in sensitive areas such as the face, groin, and underarms3-5,13
- Other prescription (not FDA approved) and non-prescription treatments have not been proven effective5,8,11
*Data from a 2013 study in 306 children in the United Kingdom between the ages of 4 and 15 years who were followed monthly to determine their recovery from molluscum contagiosum and transmission to other children in the household.2
INDICATION
ZELSUVMI is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 1 year of age and older.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Application site reactions, including allergic contact dermatitis, have occurred in patients treated with ZELSUVMI. Suspect allergic contact dermatitis in the event of pain, pruritus, swelling, or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue ZELSUVMI and initiate appropriate therapy.
ADVERSE REACTIONS
The most commonly reported adverse reactions (incidence ≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). Other adverse reactions include pyrexia (2.2%), vomiting (1.3%), and upper respiratory tract infection (1.2%).
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with use of ZELSUVMI in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Lactation: There are no data on the presence of berdazimer in human or animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZELSUVMI and potential adverse effects on the breastfed child.
Pediatric: The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may request medical information and report adverse events or product complaints to Pelthos Inc. by calling 1-855-330-7546 or sending an email to medinfo@pelthos.com.
Please see the full Prescribing Information and Instructions for Use for ZELSUVMI.
References: 1. Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. Ped Derm. 2015;32(3):353-357. 2. Olsen JR, Gallacher J, Finlay A, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15:190-195. 3. Hebert AA, Bhatia N, Del Rosso JQ. Molluscum contagiosum: epidemiology, considerations, treatment options, and therapeutic gaps. J Clin Aesthet Dermatol. 2023;16(8 suppl 1):S4-S11. 4. Molluscum contagiosum: overview. American Academy of Dermatology. Accessed December 9, 2024. https://www.aad.org/public/diseases/a-z/molluscum-contagiosum-overview 5. Leung AKC, Barankin B, Hon KLE. Molluscum contagiosum: an update. Recent Pat Inflamm Allergy Drug Discov. 2017;11(1):22-31. 6. van der Wouden JC, van der Sande R, Kruithof EJ, Sollie A, van Suijlekom-Smit LWA, Koning S. Interventions for cutaneous molluscum contagiosum (Review). In: Cochrane Database of Systemic Reviews. Issue 5. John Wiley & Sons, Ltd.; 2017. doi:10.1002/14651858.CD004767.pub4 7. Schaffer JV, Berger EM. Molluscum contagiosum. JAMA Dermatol. 2016;152(9):1072. 8. Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878. 9. Han H, Smythe C, Yousefian F, Berman B. Molluscum contagiosum virus evasion of immune surveillance: a review. J Drugs Dermatol. 2023;22(2):182-189. 10. US Census Bureau. QuickFacts: United States. Accessed May 16, 2025. https://www.census.gov/quickfacts/fact/table/US/PST045224 11. Cartwright M, Maeda-Chubachi T, Enloe C, Stripling S, Hebert A. How are pediatricians treating molluscum contagiosum? Results from in-depth interviews. Open J Pediatr Child Health. 2024;9(1):040-044. 12. Chapa PJ, Mavura DR, Philemon R, Kini L, Masenga EJ. Contributing factors and outcome after cryotherapy of molluscum contagiosum among patients attending tertiary hospital, northern Tanzania: a descriptive prospective cohort study. Derm Res Pract. 2021;2021:9653651. doi:10.1155/2021/9653651 13. Gerlero P, Hernandez-Martin A. Update on the treatment of molluscum contagiosum in children. Actas Dermosifiliogr (Engl Ed). 2018;109(5):408-415.