Molluscum ContagiosumPhase 2NCT03077750
A Study of VBP-245 in Pediatric Patients With Molluscum Contagiosum
A Phase 2 study testing VBP-245 Topical Gel in people with Molluscum Contagiosum, run by Veloce BioPharma LLC at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- VBP-245 Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2017to 27 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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 -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Parkside Pediatrics
Greenville, South Carolina, 29607
Coastal Pediatrics
Mt. Pleasant, South Carolina, 29464
About this study
Official title: 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).
- Conditions
- Molluscum Contagiosum
- Being tested
- VBP-245 Topical Gel, Vehicle
- Keywords
- viral skin disease
- Medical subject headings
- Molluscum Contagiosum, Skin Diseases, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBP-245 Topical GelDrug
Topical application BID
VehicleDrug
Vehicle Control With No Active Pharmaceutical Ingredients
| Study group | Role | What they receive |
|---|---|---|
| VBP-245 | Experimental | VBP-245 Topical Gel Applied to Affected Area BID Receives: Drug: VBP-245 Topical Gel |
| Vehicle | Placebo comparator | Vehicle Gel Applied to Affected Area BID Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start27 Feb 2017
- Primary completion30 Mar 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molluscum ContagiosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veloce BioPharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jayashri Krishnan, PhD, Study director, JSS Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077750
- Sponsor's protocol ID
- VBP-245-MCV
- Status last verified
- Oct 2018
- First submitted
- 31 Jan 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03077750
- Acronym / sponsor ID
- VBP-245-MCV
- Conditions
- Molluscum Contagiosum
- Keywords
- viral skin disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Veloce BioPharma LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VBP-245 | Experimental | Drug: VBP-245 Topical GelVBP-245 Topical Gel Applied to Affected Area BID |
| Vehicle | Placebo comparator | Drug: VehicleVehicle Gel Applied to Affected Area BID |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VBP-245 Topical GelTopical application BID | Drug | VBP-245 |
| VehicleVehicle Control With No Active Pharmaceutical Ingredients | Drug | Vehicle |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayashri Krishnan, PhD study director
JSS Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VBP-245 Topical Gel in people with Molluscum Contagiosum, run by Veloce BioPharma LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in number of MCV lesions (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.