| CTRI Number |
CTRI/2025/08/093570 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing effectiveness of antiviral (acyclovir) as oral medication, cream and local injection form for genital (Private area) and anal warts. |
|
Scientific Title of Study
|
Comparative efficacy of oral, topical and
intralesional acyclovir in anogenital warts |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Dogra |
| Designation |
PG JR Dermatology |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Dermatology, D- Block 4th Floor, Govt. Medical College and Hospital Chandigarh, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9697764906 |
| Fax |
|
| Email |
drrahuldogra1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Gurvinder Pal Thami |
| Designation |
Professor And Head |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Dermatology, D- Block 4th Floor, Govt. Medical College and Hospital Chandigarh, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121544 |
| Fax |
|
| Email |
thamigp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Dogra |
| Designation |
PG JR Dermatology |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Dermatology, D- Block 4th Floor, Govt. Medical College and Hospital Chandigarh, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9697764906 |
| Fax |
|
| Email |
drrahuldogra1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Dermatology, D- Block 4th Floor, Govt. Medical College and Hospital Chandigarh, Sector 32, Chandigarh |
| 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 Rahul Dogra |
Government Medical college and hospital Chandigarh |
Department of dermatology, 5th Floor D- Block, GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9697764906
drrahuldogra1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A630||Anogenital (venereal) warts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intralesional acyclovir 70mg/ml |
Patients will be given intralesional acyclovir 70mg/ml once a week for 4 weeks. |
| Intervention |
Oral Tab Acyclovir 400mg |
Patients will be given oral acyclovir tablets in the
dose of 400mg thrice a day for 4 weeks. |
| Intervention |
Topical 5% acyclovir
cream |
Patients will be given topical 5% acyclovir
cream thrice a day for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients having lesions of anogenital warts. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or females planning for pregnancy or lactating mothers.
2.Immunocompromised individuals including HIV-AIDS.
3.Patients with known hypersensitivity to acyclovir or its components or any contraindications to acyclovir e.g. renal failure.
4.Patients having any significant systemic illness.
5.Patients having taken any other treatments for anogenital warts in the last 4 weeks. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the resolution of lesions |
Every week for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the resolution/recurrence of lesions |
at 8 weeks, after 4 weeks of stoppage of therapy |
| To assess the adverse effects of oral, topical and intralesional formulations of acyclovir |
8 weeks total study duration |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
04/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Acyclovir, a nucleoside analogue, is an antiviral agent and have shown efficacy as an intralesional agent in warts. Hence may be used for anogenital warts in various administrations. Forty-five consecutive patients of anogenital warts will be recruited for the study and divided into 3 groups of 15 each. Group A patients will be given oral acyclovir in the dose of 400mg thrice a day for 4 weeks. Group B patients will be given topical 5 percent acyclovir cream thrice a day for 4 weeks. Group C patients will be given intralesional acyclovir 70mg per ml once a week for 4 weeks. Each patient shall be followed every week for 4 weeks of therapy and also at additional 4 weeks of stoppage of therapy. Clinical response will be documented at each visit by evaluating the decrease in lesion count, decrease in size of lesions an presence of any side effects.
|