Molluscum Contagiosum
Conditions
Keywords
viral skin disease
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).
Interventions
DRUGVBP-245 Topical Gel
Topical application BID
DRUGVehicle
Vehicle Control With No Active Pharmaceutical Ingredients
Sponsors
Veloce BioPharma LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in number of MCV lesions | 60 days | Number of lesions from baseline to day 60 will be counted and the reduction in number will be recorded. |
Countries
United States
Outcome results
None listed