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

October 9, 2018 updated by: Veloce BioPharma LLC

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

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).

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Fort Washington, Pennsylvania, United States, 19034
        • Philadelphia Institute of Dermatology
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Parkside Pediatrics
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria:

  1. Males or females aged 2-18 years at screening;
  2. MC diagnosed by a general physician, dermatologist or pediatrician who refers it and treatable by a topical agent;
  3. Individuals with at least 1, but not exceeding 15 molluscum selected in designated treatment area:
  4. 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;
  5. 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;
  6. 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;
  7. Parent or guardian able to give appropriate informed consent as determined by the approving institutional review board (IRB);
  8. Individuals who are generally in good health as determined by the investigator;
  9. 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;
  10. 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;
  11. Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s);
  12. Individuals who are willing and able to thoroughly follow the product use instructions, attend all the scheduled visits and successfully complete the study;
  13. Individuals who are willing and able to not begin any office based treatments for the duration of the study;
  14. Female subjects of childbearing age with negative pregnancy test at the enrolment time in the study;
  15. Female subjects who are not breastfeeding at the enrolment time in the study;
  16. Female subjects that do not intend to become pregnant during their participation in the study;
  17. Female subjects with reproductive potential must agree to practice medically acceptable form of birth control during the study • Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include: o Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring) Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/Vault caps) with a spermicidal foam/gel/film/cream or suppository; o Intrauterine divide (IUD) or intrauterine system (IUS); o Surgical sterilization (vasectomy, tubal occlusion, bilateral salpingectomy); Abstinence from heterosexual intercourse; when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are NOT acceptable methods of contraception

Exclusion Criteria:

Subjects meeting the following exclusion criteria will be excluded from the study:

  1. Mentally incompetent or unable or not willing to give written informed consent via parent or guardian or meet study requirements
  2. Known history of hypersensitivity to topical povidone-iodine
  3. Significant atopic dermatitis surrounding the molluscum contagiosum lesions as judged by the investigator
  4. Individual lesions greater than 5mm in diameter
  5. Pregnant, breastfeeding or unwilling to undergo an acceptable form of contraception for the duration of the study;
  6. 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;
  7. Have participated in an investigational trial within 30 days prior to enrollment;
  8. 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.
  9. Have any uncontrolled current infection;
  10. Female subject who is pregnant, lactating planning to become pregnant, or is breastfeeding;
  11. 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);
  12. 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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VBP-245
VBP-245 Topical Gel Applied to Affected Area BID
Topical application BID
Placebo Comparator: Vehicle
Vehicle Gel Applied to Affected Area BID
Vehicle Control With No Active Pharmaceutical Ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in number of MCV lesions
Time Frame: 60 days
Number of lesions from baseline to day 60 will be counted and the reduction in number will be recorded.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jayashri Krishnan, PhD, JSS Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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