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
|
|
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
|
|
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. |