ZELSUVMI was studied in the largest randomized clinical trial ever conducted for the treatment of molluscum1,2
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group, phase 3 study to evaluate the efficacy and safety of ZELSUVMI in 891 patients1,2
The primary efficacy end point1,2
-
Percentage of patients who achieved complete clearance of all treatable* molluscum lesions at Week 12
The secondary efficacy end points1,2
-
Percentage of patients who achieved a 90% or greater reduction from baseline in the number of lesions at Week 12
-
Percentage of patients who achieved a molluscum lesion count of 0 or 1 at Week 12
-
Percentage of patients who achieved complete clearance of lesions at Week 8
-
Percent change from baseline in the number of lesions at Week 4
Study Details
ZELSUVMI
n=444
Vehicle
n=447
ZELSUVMI was applied during study visits at baseline and Week 2, 4, 8, and 12, and at home on other days. If all lesions were cleared at a study visit, the patient's treatment period ended and patients were followed for recurrence or appearance of new lesions until Week 24.2
*Treatable lesions were defined as active (palpable) molluscum lesions at least 2 cm away from the ocular region.2
Patient characteristics were comparable between treatment groups
Baseline demographic information and clinical characteristics of study participants2
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| Characteristic | ZELSUVMI n=444 |
Vehicle gel n=447 |
|---|---|---|
| Age, mean (range), years | 6.6 (0.9 – 47.5) | 6.5 (1.3 – 49) |
| Sex, n (%) | ||
| Male | 228 (51.4) | 213 (47.7) |
| Female | 216 (48.6) | 234 (52.3) |
| Race and ethnicity, n (%) | ||
| Asian | 6 (1.4) | 6 (1.3) |
| Black or African American | 21 (4.7) | 28 (6.3) |
| Hispanica | 94 (21.2) | 87 (19.5) |
| Otherb | 30 (6.8) | 31 (6.9) |
| White | 387 (87.2) | 382 (85.5) |
| Mean baseline lesion count (range) | 23.1 (3 – 70) | 20.5 (3 – 69) |
| Baseline BOTE score, n (%)c | ||
| 0 (no inflammation) | 225 (50.7) | 223 (49.9) |
| ≥1 (mild to very severe) | 219 (49.3) | 224 (50.1) |
| Median age at awareness of lesions (range), years | 4.8 (0.2 – 46.9) | 4.9 (0 – 37.3) |
| Mean months since awareness of lesions (range) | 12.0 (0.2 – 153.3) | 13.1 (0 – 192.8) |
| Patients randomized per household, n (%)d | ||
| 1 patient | 403 (90.8) | 406 (90.8) |
| 2 patients | 41 (9.2) | 41 (9.2) |
aIndividuals of Hispanic and Latino ethnicity are also included in the numbers by race because race and ethnicity were treated separately for data collection.
bIncludes American Indian, Alaska Native, Native Hawaiian, and other Pacific Islanders.
cAverage for all lesions.
dPercentages based on total number of households.
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. ZELSUVMI Package Insert. EPIH SPV, LLC. 2024. 2. 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.