CTRI/2017/08/009409Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase II Study to Evaluate the Efficacy, Tolerability, and Safety of Topical Povidone-Iodine (PVP-I, 2% [W/W]) in Pediatric Subjects for the Treatment of Molluscum Contagiosum
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Veloce BioPharma LLC
- Enrollment
- 110
- Locations
- 10
- Primary Endpoint
- Complete resolution of all lesions at Day 60, recorded at the baseline visit
Study Overview
Brief Summary
A randomized, double blind phase II clinical trial to study the effects of topical Povidone-Iodine (2%) gel in children for the Treatment of Molluscum Contagiosum.
Primary aim is to evaluate the efficacy of the topical PVP-I 2% gel (vbp-245) in children with Molluscum Contagiosum. Secondary aim is to evaluate the tolerability and safety.
Subjects will be randomized 1:1 to receive either the test product or comparator. A total of four visits are planned including one screening/baseline (Visit 1) and three follow-ups (Visit 2: 14 days; Visit 3:35 days; and Visit 4: 60 days).
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
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 events
- •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 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
- •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 enrollment 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 Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include 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; Intrauterine divide or intrauterine system; 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
- •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 PVP-I
- •Significant atopic dermatitis surrounding the MC lesions as judged by the Investigator
- •Individual lesions greater than 5 mm 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; 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 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);
- •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.
Outcomes
Primary Outcomes
Complete resolution of all lesions at Day 60, recorded at the baseline visit
Time Frame: Day 60
Secondary Outcomes
- Change in the number of lesions (worsening or increase in number, no change or decrease in number but not complete)(Day 60)
Investigators
Study Sites (10)
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