A Study of VBP-245 in Pediatric Patients With Molluscum Contagiosum

NCT03077750 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: VBP-245-MCV
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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).

Conditions

Molluscum Contagiosum

Keywords

viral skin disease

Outcome Measures

Primary Outcomes (1)

• Reduction in number of MCV lesions

  Number of lesions from baseline to day 60 will be counted and the reduction in number will be recorded.

  60 days

Study Arms (2)

VBP-245

EXPERIMENTAL

VBP-245 Topical Gel Applied to Affected Area BID

Drug: VBP-245 Topical Gel

Vehicle

PLACEBO COMPARATOR

Vehicle Gel Applied to Affected Area BID

Drug: Vehicle

Interventions

VBP-245 Topical Gel DRUG

Topical application BID

VBP-245

Vehicle DRUG

Vehicle Control With No Active Pharmaceutical Ingredients

Vehicle

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• Individuals who are willing to not start any new products OTC or prescription treatments and discontinue any treatment the investigator feels may interfere with the evaluation of the test products;
• Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s);
• Individuals who are willing and able to thoroughly follow the product use instructions, attend all the scheduled visits and successfully complete the study;
• Individuals who are willing and able to not begin any office based treatments for the duration of the study;
• Female subjects of childbearing age with negative pregnancy test at the enrolment time in the study;
• Female subjects who are not breastfeeding at the enrolment time in the study;

You may not qualify if:

• 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;
• Female subject who is pregnant, lactating planning to become pregnant, or is breastfeeding;
• Have any chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk (such as an immunodeficiency or relevant genetic syndrome);
• Have any active malignancy or are undergoing treatment for any malignancy other than non-melanoma skin cancer; Subjects viewed by the Principal Investigator as not being able to complete the study -

Sponsors & Collaborators

• Veloce BioPharma LLC: lead

Study Sites (3)

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

Parkside Pediatrics

Greenville, South Carolina, 29607, United States

Location

Coastal Pediatrics

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Molluscum Contagiosum; Skin Diseases, Viral

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jayashri Krishnan, PhD

  JSS Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: March 13, 2017
• Study Start: February 27, 2017
• Primary Completion: March 30, 2018
• Study Completion: April 27, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)