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

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