| CTRI Number |
CTRI/2022/07/044451 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
25/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of acyclovir and bleomycin injection in treatment of warts |
|
Scientific Title of Study
|
A comparative study of efficacy of intra-lesional Bleomycin versus intra-lesional Acyclovir in management of warts |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eeshaan ranjan |
| Designation |
Assistant professor |
| Affiliation |
military hospital jammu |
| Address |
Dept of Dermatology
Military hospital
Jammu. Pin- 180003
Jammu
JAMMU & KASHMIR
180003
India |
| Phone |
9720639323 |
| Fax |
|
| Email |
eeshaan.ranjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eeshaan ranjan |
| Designation |
Assistant professor |
| Affiliation |
military hospital jammu |
| Address |
Dept of Dermatology
Military hospital
Jammu. Pin- 180003
Jammu
JAMMU & KASHMIR
180003
India |
| Phone |
9720639323 |
| Fax |
|
| Email |
eeshaan.ranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Eeshaan ranjan |
| Designation |
Assistant professor |
| Affiliation |
military hospital jammu |
| Address |
Dept of Dermatology
Military hospital
Jammu. Pin- 180003
Jammu
JAMMU & KASHMIR
180003
India |
| Phone |
9720639323 |
| Fax |
|
| Email |
eeshaan.ranjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Military hospital
Jammu. Pin- 180003 |
|
|
Primary Sponsor
|
| Name |
Military hospital |
| Address |
Dept of Dermatology
Military hospital
Jammu. Pin- 180003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 eeshaan ranjan |
Military Hospital jammu |
Dept of Dermatology
Military hospital
Jammu
Jammu
JAMMU & KASHMIR |
8383058229
eeshaan.ranjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical commitee, 166 MILITARY HOSPITAL, JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B079||Viral wart, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection acyclovir 70mg/ml intralesional |
Intralesional acyclovir injection at 0, 4 weeks. total of 2 injections |
| Comparator Agent |
Injection bleomycin 1mg/ml intralesional |
Intralesional bleomycin injection at 0 and 4 weeks. total of 2 injections. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years with clinical diagnosis of warts
|
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 18 years and above the age of 60 years.
2.Patients not willing to participate in the study.
3.Pregnant or lactating females.
4. Patients with any systemic illness
5. Patient with history of treatment of warts in last 6 months
7.Patients having hypersensitivity to bleomycin or acyclovir
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical resolution of warts |
clinical resolution of warts at 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient satisfaction score |
at presentation and 6 months after treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Warts are the manifestations of human papilloma
virus (HPV) infection. Intralesional bleomycin has
been used for the treatment of warts since the 1970s with high efficacy even at
low concentration. It is proven to be effective with resolution rates of more than 90%. Injection acyclovir is a newer treatment modality reported to be effective in treatment of warts. Thus, we plan to conduct a randomized, controlled trial in order to
evaluate the safety and efficacy of intralesional injection acyclovir in comparison to intralesional injection bleomycin. |