| CTRI Number |
CTRI/2025/04/085453 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of Bleomycin injection versus Tuberculin Purified Protein Derivative injection in cutaneous warts. |
|
Scientific Title of Study
|
A Comparative study of intralesional Bleomycin injection versus Tuberculin Purified Protein Derivative in the treatment of cutaneous warts: A prospective study from a tertiary care centre. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moin Ahmad Siddiqui |
| Designation |
Assistant Professor |
| Affiliation |
Eras Lucknow Medical College and Hospital |
| Address |
Department of Dermatology, Second floor, Eras Lucknow Medical College and Hospital, Sarfaraz ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8218382301 |
| Fax |
|
| Email |
moinahmad12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Moin Ahmad Siddiqui |
| Designation |
Assistant Professor |
| Affiliation |
Eras Lucknow Medical College and Hospital |
| Address |
Department of Dermatology, Second floor, Eras Lucknow Medical College and Hospital, Sarfaraz ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8218382301 |
| Fax |
|
| Email |
moinahmad12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Moin Ahmad Siddiqui |
| Designation |
Assistant Professor |
| Affiliation |
Eras Lucknow Medical College and Hospital |
| Address |
Department of Dermatology, Second floor, Eras Lucknow Medical College and Hospital, Sarfaraz ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8218382301 |
| Fax |
|
| Email |
moinahmad12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eras Lucknow Medical College and Hospital, Sarfaraz ganj Lucknow 226003 |
|
|
Primary Sponsor
|
| Name |
Eras Lucknow Medical College and Hospital Lucknow |
| Address |
second floor, Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfaraz Ganj Lucknow |
| Type of Sponsor |
Private 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 Moin Ahmad Siddiqui |
Eras Lucknow Medical College and Hospital |
Department of Dermatology, Second floor, Eras Lucknow Medical College and Hospital, Sarfarzganj Lucknow
Lucknow
UTTAR PRADESH |
08218382301
moinahmad12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Bleomycin |
1 vial of injection bleomycin containing 15 IU is diluted with 5 ml of normal saline to prepare the stock solution.(15 IU/5 ml).
follow up baseline, every 3rd week till the lesion is resolved
2 parts of 2% lidocaine and 1 part of stock solution is mixed (1mg/ml) and injected into the base of wart. |
| Comparator Agent |
Tuberculin purified protein derivative |
Tuberculin purified protein derivative is injected into the base of wart
follow up- baseline, every 3 weeks till the lesion is resolved |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have not taken any treatment for warts in the past 4 weeks. |
|
| ExclusionCriteria |
| Details |
1 Patients with local skin infection, hypersensitivity to Bleomycin, allergic skin diseases.
2 Pregnant and lactating women
3 Immunosuppressed patients or patients on immunosuppressive therapy
4 Patients with history of any other systemic illness.
5 Patients refusing consent. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the response of Intralesional bleomycin better than tuberculin purified protein derivative in cases of cutaneous warts |
baseline, then every 3 weeks till resolution of lesions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Warts are a common, benign, and usually a self-limited disease affecting skin and mucous membrane caused by human papilloma virus (HPV) by infecting keratinocytes which results in cell proliferation and a thickened, warty papule. Human papilloma viruses (HPVs) are a family of small, nonenveloped, double-stranded DNA viruses that cause benign epithelial proliferations or warts. Usually, warts are self- limiting in nature and can disappear after a few months or can stay for years and even reoccur depending upon host susceptibility and immunity. Management of warts has become a challenge for the dermatologist due to their resistance to treatment and their refractory nature. Various treatment modalities are available for the management of warts. Intralesional bleomycin and purified protein derivative are new therapeutic modalities in the management of warts. |