| CTRI Number |
CTRI/2024/03/063810 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To Compare the efficacy of 20% Podophyllin and 100% Trichloroacetic acid in the treatment of anogenital warts |
|
Scientific Title of Study
|
A Comparative study on the efficacy of 20% Podophyllin versus 100% Trichloroacetic acid in the treatment of 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 S Ramya |
| Designation |
Postgraduate |
| Affiliation |
Chengalpattu Medical College and Hospital |
| Address |
Department of DVL
Chengalpattu Medical College and Hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9791971803 |
| Fax |
|
| Email |
ramyasubramanian33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Jayakalyani |
| Designation |
Assistant professor |
| Affiliation |
Chengalpattu Medical College and Hospital |
| Address |
Department of DVL
Chengalpattu Medical college and hospital
No 45 GST road
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8110082516 |
| Fax |
|
| Email |
dermcliniccmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Ramya |
| Designation |
Postgraduate |
| Affiliation |
Chengalpattu Medical College and Hospital |
| Address |
Department of DVL
Chengalpattu Medical College and Hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9791971803 |
| Fax |
|
| Email |
ramyasubramanian33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of DVL
Chengalpattu medical college and hospital
Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr S Ramya |
| Address |
Chengalpattu Medical College and Hospital, Chengalpattu |
| Type of Sponsor |
Other [Self] |
|
|
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 S Ramya |
Chengalpattu Medical College and Hospital |
OP No 44
STD OPD
Department of DVL
Kancheepuram
TAMIL NADU |
9791971803
ramyasubramanian33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Chengalpattu Medical College and Hospital |
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 |
| Comparator Agent |
100% Trichloroacetic acid |
Patients in group B with anogenital warts will be treated with 100% trichloroacetic acid application weekly once for 6 weeks and followed up at 2 weeks interval for another 6 weeks for a total duration of 12 weeks |
| Intervention |
20% Podophyllin |
Patients in group A with anogenital wart will be treated with 20% podophyllin application weekly once for 6 weeks and followed up 2 weeks interval for another 6 weeks for a total duration of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with anogenital warts willing to give written informed consent will be divided into group A and group B.25 Patients in group A will receive 20%
podophyllin.25 Patients in group B will receive 100% TCA. Maximum 6 sittings will be given at
weekly interval. Patients will receive no other therapies during the study. Patients will be advised
partner screening and usage of barrier contraception during the study. |
|
| ExclusionCriteria |
| Details |
Before starting the study
Pregnant and lactating women.
During the study
If patient develops severe side effects
like ulceration / intolerant to pain during
the treatment.
If patient wants alternate treatment
during the study.
If patient wants to discontinue the
treatment. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement or resolution of anogenital warts |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disappearance or Recurrence of of anogenital warts |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2024 |
| 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 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
|
Wart is a viral infection caused by human papilloma virus (HPV). It can affect both the skin and the mucosa. Anogenital warts refer to the infection of anal and genital mucosa and their adjacent areas. It is mainly transmitted through sexual contact. The lesions appear after the incubation period of 1to 8 months (average 3 months). Anogenital warts may be single or multiple. In men, genital warts most commonly occur on the inner lining of prepuce, frenulum, glans, coronal sulcus, urinary meatus, penile shaft and scrotum. In women, common sites involved are posterior part of introitus, labia, perineum and perianal area, also can involve vagina and cervix. The common presentation is a verrucous papules or pedunculated lesions that may coalesce to form verrucous plaques or cauliflower like growth. Generally the lesions are pink and painless. Depending upon the clinical appearance, warts can be classified as condylomata acuminata, papular wart, keratotic wart and flat topped papular wart. There are various treatment options for anogenital warts such as Podophyllin, Podophyllotoxin, Monochloroacetic acid and Trichloroacetic acid, Cryotherapy,5- Fluorouracil, Imiquimod, Surgical excision, Laser and interferon therapy. The aim of this study is to compare the efficacy of 20% podophyllin and 100% trichloroacetic acid. |