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CTRI Number  CTRI/2021/04/032610 [Registered on: 07/04/2021] Trial Registered Prospectively
Last Modified On: 26/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare efficacy of treatment by intralesional bleomycin and intralesional vitamin D-3 in common warts. 
Scientific Title of Study   Comparative therapeutic efficacy of intralesional bleomycin and intralesional vitamin D-3 in verruca vulgaris. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ritu Mittal 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical college and Hospital  
Address  Department of Dermatology, Venereology and Leprosy, Block D, Level 5, GMCH, Sector 32, Chandigarh
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  9646497534  
Fax    
Email  mittalritu23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gurvinder Pal Thami 
Designation  Professor and Head 
Affiliation  Government Medical college and Hospital 
Address  Department of Dermatology, Venereology and Leprosy, Block D, Level 5, GMCH, Sector 32, Chandigarh
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  9646121544  
Fax    
Email  thamigp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ritu Mittal 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical college and Hospital 
Address  Department of Dermatology, Venereology and Leprosy, Block D, Level 5, GMCH, Sector 32, Chandigarh
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  9646497534  
Fax    
Email  mittalritu23@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital sector 32 Chandigarh 
 
Primary Sponsor  
Name  Department of Dermatology Venereology and Leprosy 
Address  Department of Dermatology, Venereology and Leprosy, Block D, Level 5, GMCH, Sector 32, Chandigarh 160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritu Mittal  Government Medical College and Hospital  Department of Dermatology, Venereology and Leprosy, Block D, Level 5, GMCH, Sector 32 Chandigarh
Chandigarh
CHANDIGARH 
9646497534

mittalritu23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Core Committee GMCH Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B078||Other viral warts,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bleomycin   Bleomycin solution with a concentration of 1 mg/ml will be administered intralesionally into the base of the wart depending on the size of the lesion. Warts up to 5 mm will receive 0.2 ml, those up to 10 mm will receive 0.2-0.5 ml and larger warts will receive up to 1.0 ml. A maximum dose of 1 ml will be injected per wart and the total cumulative dose shall not exceed 2 ml in one session. Three such sessions will be done at an interval of 2 weeks (i.e. 0, 2 and 4 weeks). 
Comparator Agent  Vitamin D-3  Vitamin D-3 solution with a concentration of 15 mg/ml (6,00,000 IU) will be administered intralesionally into the base of the wart till blanching occurs. A maximum dose of 0.5 ml will be injected per wart and the total cumulative dose shall not exceed 2 ml in one session. Three such sessions will be done at an interval of 2 weeks (i.e. 0, 2 and 4 weeks) 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All untreated consecutive patients having single/ multiple lesions of verruca vulgaris.
2. Patients above the age of 14 years. 
 
ExclusionCriteria 
Details  1. Pregnant or lactating females.
2. Immunocompromised individuals including HIV.
3. Patients known to have hypersensitivity to vitamin D-3.
4. Patients having history of peripheral vascular disorders like scleroderma or Raynaud’s phenomenon.
5. Patients with pulmonary fibrosis.
6. History of intake of vitamin D-3, anabolic steroids, bisphosphonates in the last 3 months or history of intravenous chemotherapy with bleomycin in the past.
7. Patients having any significant systemic illness.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the therapeutic efficacy of intralesional bleomycin and intralesional vitamin D-3 in verruca vulgaris.  A total of three sessions at an interval of two weeks shall be instituted in both groups (i.e. 0, 2 and 4 weeks). Patients will be followed at 8th week. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/04/2021 
Date of Study Completion (India) 01/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None as yet. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Verruca vulgaris or common warts, caused by Human Papilloma Virus presents as asymptomatic skin coloured, firm papules with a rough verrucous surface. Although no single therapy is considered as gold standard, multiple therapeutic options available for warts are:
1. Topical therapies- keratolytic agents such as salicylic acid; cytotoxic agents like 5-Fluorouracil, bleomycin and podophyllin; immunomodulators like imiquimod and caustics such as trichloroacetic acid.
2. Destructive therapies- electrofulguration, cryotherapy, laser ablation, excision, hyperthermia and photodynamic therapy.
3. Immunotherapies- vaccines such as BCG, MMR, Mycobacterium w; antigens such as candid antigen, PPD, vitamin D-3, IFN-alpha and contact sensitizers.
        Topical therapy generally requires multiple sessions which results in poor patient compliance and has a higher risk of recurrence. Destructive modalities often require expensive equipment, cause scarring and dyspigmentation.
         Immunotherapy has evoloved as a potential treatment modality for treatment of warts which acts by activating the patient’s immune system thus enhancing recognition and eradication of the virus. Vitamin D-3 is a recent introduction as immunotherapeutic agent which regulates epidermal proliferation and cytokine production.
         Bleomycin, a cytotoxic agent has been U.S FDA approved for the treatment of various malignancies. When administered into the skin, it leads to apoptosis of keratinocytes by causing DNA breaks, endothelial cell sclerosis, and inhibition of collagen formation. The therapeutic efficacy of bleomycin in warts have been assessed by using various concentrations, doses and different methods of administration.
          This study aims at comparing the therapeutic efficacy of intralesional bleomycin and intralesional vitamin D-3 in verruca vulgaris.
 
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