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CTRI Number  CTRI/2017/08/009409 [Registered on: 18/08/2017] Trial Registered Prospectively
Last Modified On: 19/03/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of 2% Povidone-Iodine Gel to be applied locally on skin in children for the Treatment of viral infection Molluscum Contagiosum. 
Scientific Title of Study   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 Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT03077750  ClinicalTrials.gov 
VBP-245-MCV; Version No. 1.0 Dated 15 Nov 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayashri Krishnan 
Designation  Deputy Head -Clinical Operations 
Affiliation  JSS Medical Research India Private Limited 
Address  No 13, 45th Street, Nanganallur,

Chennai
TAMIL NADU
600061
India 
Phone  91-9771407484  
Fax    
Email  jayashri.krishnan@jssresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonika Newar  
Designation  Medical Monitor 
Affiliation  JSS Medical Research India Private Limited 
Address  6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D

Faridabad
HARYANA
121003
India 
Phone  91-8800799887  
Fax  01296613520  
Email  sonika.newar@jssresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Shariq Anwar  
Designation  Head-Operations  
Affiliation  JSS Medical Research India Private Limited 
Address  6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D

Faridabad
HARYANA
121003
India 
Phone  91-9810979215  
Fax  01296613520  
Email  shariq.anwar@jssresearch.com  
 
Source of Monetary or Material Support  
Veloce BioPharma LLC, 1007 N Federal Hwy #E4 Fort Lauderdale, FL 33304, U.S.A  
 
Primary Sponsor  
Name  Veloce BioPharma LLC 
Address  1007 N Federal Hwy #E4 Fort Lauderdale, FL 33304, U.S.A  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shatrughan Sahay  Ajanta Research Centre, Ajanta Hospital & IVF Centre  Department of Dermatology, Basement Floor, 765, ABC complex, Knapur road, Alambagh- 226005
Lucknow
UTTAR PRADESH 		 91-9412119129

Arc.hospital@yahoo.com 
Dr A M Jayaraman  Chennai Meenakshi Multispeciality Hospital  Ground Floor OPD consultation Room Old # 148, New # 72, Luz Church Road, Mylapore– 600 004,
Chennai
TAMIL NADU 		 91-9444119274

jayaraamana@gmail.com 
Dr Vipul Gupta  KRM Hospital and Research Centre  Department of Dermatology and cosmetology, Ground Floor OPD Room 4 Vijyant Khand, Gomti Nagar, Pin-226010
Lucknow
UTTAR PRADESH 		 91-9838172269

krmhrclko@gmail.com 
Dr Rachita Dhurat  Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital (LTMMC & GH)  Department of Dermatology, OPD no. 16, 2nd floor, New OPD building, LTMMC and GH, Pin- 400022
Mumbai
MAHARASHTRA 		 91-9870390057

rachitadhurat@yahoo.co.in 
Dr Dinesh Chandra Pandey  M.V Hospital and Research Centre,   Pediatrics Department Ground Floor OPD Room No2, 314/30, Mirza Mandi chowk, Pin- 226003
Lucknow
UTTAR PRADESH 		 91-9415156419

dr_dc_pandey@yahoo.com 
Dr Ashish R Deshmukh  Mahatma Gandhi Missions Medical College & Hospital  Department of Dermatology, OPD, Ground Floor, N-6, CIDCO, Pin-431003
Aurangabad
MAHARASHTRA 		 91-9422213292

rmgmpharmacologydept@gmail.com 
Dr Amit Kumar Malhotra  Marudhar Hospital,   Department of Dermatology, Basement Floor A-93,99 Singh bhoomi, Khatipura, Pin- 302012
Jaipur
RAJASTHAN 		 91-8875127902

dramitmalhotra@gmail.com 
Dr Davinder Parsad  Nehru Hospital, PGIMER  Post Graduate Institute of Medical Education and Research (PGIMER), Department of Dermatology, OPD Floor No- 5 Sector 12, Pin-160012
Chandigarh
CHANDIGARH 		 91-9432146692

parsad@me.com 
Dr Pravin Kumar Shetty  Sahyadri Hospital  Department of Dermatology, First floor Plot no.9 B Neena Society S. No. 148/A/B, Paud Road, Opp. Vanaz Factory, Kothrud, Pin- 411 038
Pune
MAHARASHTRA 		 91-9822060266

pravincutis@yahoo.co.in 
Dr Nikhil Kajale  Sahyadri Speciality Hospital,   Department of Dermatology, Ground floor Mumbai Agra road, near Dwarka circle, Wadala road, Nashik -422002
Nashik
MAHARASHTRA 		 919619841393

niks_kajale@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Chennai Meenakshi Multi Speciality Hospital Ethics Committee  Approved 
Institutional ethics committee M.V Hospital and Research Centre  Approved 
Institutional ethics committee, Ajanta Research Centre, Ajanta Hospital & IVF Centre  Approved 
Institutional ethics committee, PGIMER  Approved 
KRM Hospital Ethics committee  Approved 
Lokmanya Tilak Municipal College and Lokmanya Tilak Municipal General Hospital IEC- Human Research  Submittted/Under Review 
Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects  Approved 
Marudhar Hospital ethics committee  Approved 
Sahyadri hospitals limited ethics committee  Approved 
Sahyadri hospitals limited ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B081||Molluscum contagiosum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  VBP-245   Dose: Apply a small pea sized amount of gel to each lesion in the affected area. Frequency to apply is Twice daily. Route of administration is Topical. Total Duration of therapy: 60 days 
Comparator Agent  Vehicle control  Dose: apply a small pea sized amount of gel to each lesion in the affected area. Frequency to apply is Twice daily. Route of administration is Topical. Total Duration of therapy: 60 days  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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 events
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 enrollment 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
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
 
 
ExclusionCriteria 
Details  1. Mentally incompetent or unable or not willing to give written informed consent via parent or guardian or meet study requirements
2. Known history of hypersensitivity to topical PVP-I
3. Significant atopic dermatitis surrounding the MC lesions as judged by the Investigator
4. Individual lesions greater than 5 mm in diameter
5. Pregnant, breastfeeding or unwilling to undergo an acceptable form of contraception for the duration of the study
6. 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
7. 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);
12. Have any active malignancy or are undergoing treatment for any malignancy other than non-melanoma skin cancer;
13. Subjects viewed by the Principal Investigator as not being able to complete the study.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Complete resolution of all lesions at Day 60, recorded at the baseline visit  Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the number of lesions (worsening or increase in number, no change or decrease in number but not complete)  Day 60 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="77" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/08/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/02/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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).

  


 
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