A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase II Study to Evaluate the Efficacy, Tolerability, and Safety of VBP-245 in Pediatric Subjects for the Treatment of Molluscum Contagiosum

Veloce BioPharma LLC3 sites in 1 country110 target enrollmentFebruary 27, 2017

ConditionsMolluscum Contagiosum

InterventionsVehicle VBP-245 Topical Gel

DrugsVBP-245 Topical Gel Vehicle

Overview

Phase: Phase 2
Intervention: Vehicle
Conditions: Molluscum Contagiosum
Sponsor: Veloce BioPharma LLC
Enrollment: 110
Locations: 3
Primary Endpoint: Reduction in number of MCV lesions
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase II Study to Evaluate the Efficacy, Tolerability, and Safety of Topical VBP-245 in Pediatric Subjects for the Treatment of Molluscum Contagiosum (VBP-245-MCV).

Registry

clinicaltrials.gov

Start Date

February 27, 2017

End Date

April 27, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Veloce BioPharma LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following inclusion criteria:
•Males or females aged 2-18 years at screening;
•MC diagnosed by a general physician, dermatologist or pediatrician who refers it and treatable by a topical agent;
•Individuals with at least 1, but not exceeding 15 molluscum selected in designated treatment area:
•Individuals whose treatment area is located anywhere on the body except for the following prohibited areas which include: eye area (including eyelids), lips, mouth cavity, nasal cavity, inner ear, palms of the hands, soles of the feet or the anogenital area;
•Free from any systemic or dermatologic disorder that, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse advents;
•Free from atopic dermatitis in the treatment area that, in the opinion of the investigator, will potentially get inflamed or irritated during the course of treatment;
•Parent or guardian able to give appropriate informed consent as determined by the approving institutional review board (IRB);
•Individuals who are generally in good health as determined by the investigator;
•Willingness and ability of parent or guardian to read, understand, and sign the IRB-approved informed consent form after the nature of the study has been fully explained and questions have been answered;

Exclusion Criteria

•Subjects meeting the following exclusion criteria will be excluded from the study:
•Mentally incompetent or unable or not willing to give written informed consent via parent or guardian or meet study requirements
•Known history of hypersensitivity to topical povidone-iodine
•Significant atopic dermatitis surrounding the molluscum contagiosum lesions as judged by the investigator
•Individual lesions greater than 5mm in diameter
•Pregnant, breastfeeding or unwilling to undergo an acceptable form of contraception for the duration of the study;
•Molluscum lesions located on the eye area (including eyelids), lips, mouth cavity, nasal cavity, inner ear, palms of the hands, soles of the feet or the anogenital area;
•Have participated in an investigational trial within 30 days prior to enrollment;
•Have required or will require systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study.
•Have any uncontrolled current infection;