- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03077750
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
Conditions
Intervention / Treatment
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
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Fort Washington, Pennsylvania, United States, 19034
- Philadelphia Institute of Dermatology
-
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South Carolina
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Greenville, South Carolina, United States, 29607
- Parkside Pediatrics
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Mount Pleasant, South Carolina, United States, 29464
- Coastal Pediatrics
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-
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:
- 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;
- Female subjects that do not intend to become pregnant during their participation in the study;
- 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:
- 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 -
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VBP-245-MCV
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.
Clinical Trials on Molluscum Contagiosum
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University of North Carolina, Chapel HillNational Center for Research Resources (NCRR); Doris Duke Charitable FoundationCompleted
-
Medical University of South CarolinaThe Skin Center Dermatology GroupCompletedVerruca Vulgaris | Molluscum Contagiosum Skin InfectionUnited States
-
Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
-
Center for Clinical Studies, TexasLEO PharmaWithdrawnMolluscum ContagiosumUnited States
-
Verrica Pharmaceuticals Inc.Paidion Research, Inc.; Instat Consulting, Inc.; Database Integrations, Inc.Completed
-
Steven R CohenCompletedMolluscum ContagiosumUnited States
-
Montefiore Medical CenterCompleted
-
Combined Military Hospital AbbottabadCompletedComparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum ContagiosumMolluscum ContagiosumPakistan
-
Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
-
Combined Military Hospital AbbottabadCompletedMolluscum ContagiosumPakistan
Clinical Trials on VBP-245 Topical Gel
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Veloce BioPharma LLCActive, not recruiting
-
Novan, Inc.CompletedAcne VulgarisUnited States
-
Glia, LLCCompletedContact Lens Discomfort | Contact Lens-induced Corneal Disorder | Contact Lens Acute Red Eye | Contact Lens-induced Corneal Fluorescein StainingUnited States
-
Rhodes Pharmaceuticals, L.P.ORA, Inc.Completed
-
Novan, Inc.CompletedAcne VulgarisUnited States
-
Maruho Co., Ltd.Leiden University Medical CenterCompletedCondylomata Acuminata (External)Netherlands
-
Maruho Co., Ltd.CompletedUsual Type Vulval Intraepithelial Neoplasia (uVIN)Netherlands
-
Maruho Co., Ltd.Completed
-
Maruho Co., Ltd.CompletedAcne VulgarisUnited States
-
Lakewood-Amedex IncPrimeVigilance; Professional Education and Research InstituteTerminated