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CTRI Number  CTRI/2024/05/067393 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two Treatment modalities in external genital warts  
Scientific Title of Study   A comparative evaluation of the therapeutic efficiency and safety of Cryo-podophyllin combination versus cryo-imiquimod combination in the treatment of external genital warts in Non-immunocompromised Adults: A Randomized clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Tilak Raj 
Designation  Assistant Professor Department of dermatology venereology and leprosy  
Affiliation  Government Medical College Amritsar 
Address  Room number 21 Department of dermatology 2nd Floor Government Medical College Amritsar Punjab India

Amritsar
PUNJAB
143001
India 
Phone  9653727009  
Fax    
Email  rakeshtraj2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Tilak Raj 
Designation  Assistant Professor Department of dermatology venereology and leprosy  
Affiliation  Government Medical College Amritsar 
Address  Room number 21 Department of dermatology 2nd Floor Government Medical College Amritsar Punjab India

Amritsar
PUNJAB
143001
India 
Phone  9653727009  
Fax    
Email  rakeshtraj2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Tilak Raj 
Designation  Assistant Professor Department of dermatology venereology and leprosy  
Affiliation  Government Medical College Amritsar 
Address  Room number 21 Department of dermatology 2nd Floor Government Medical College Amritsar Punjab India

Amritsar
PUNJAB
143001
India 
Phone  9653727009  
Fax    
Email  rakeshtraj2012@gmail.com  
 
Source of Monetary or Material Support  
Government Medical college, Amritsar Punjab- 143001  
 
Primary Sponsor  
Name  GMC Amritsar Punjab  
Address  Skin department Medical college Amritsar  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Manpreet Singh Senior Resident   Skin department Medical college Amritsar  
Dr Tejinder kaur Professor and Head   Skin department Medical college Amritsar  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Tilak Raj  Government Medical College Amritsar  Department of dermatology Room no 19 STI Clinic Second Floor Department of skin
Amritsar
PUNJAB 		 9653727009

rakeshtraj2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government medical college Amritsar, Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A630||Anogenital (venereal) warts,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cryotherapy in combination with 20% podophyllin under medical supervision   Time spot freeze technique by spray method will be used for cryotherapy under medical supervision with hand held device held perpendicular at a distance of 2cm from the genital warts until an ice ball is formed at least 2mm beyond the margin of the lesion which will be confirmed by palpating between the fingers, the duration of freeze cycle will be for 5 sec in lesions less than 5cm2, 10sec for lesions between 5 to 10 cm2 and 20sec for lesions more than 10cm2. one freezing cycle will be followed by thawing cycle which will be suggested by complete disappearance of frozen white surface. The surrounding surface will be protected by liquid paraffin. The timing of the spray will be proportional to the area affected. The podophyllin will also be applied under medical supervision taking precaution not to exceed 0.5 ml per session and less than 10cm2 to be treated at any session. patient will be kept under observation for three hours. patient will be discharged after the lesions are cleaned with soap and water. Any adverse effects observed will be recorded in the prescribed Performa. Follow-up will be done at 2 weekly intervals upto a maximum of four cycles  
Comparator Agent  cryotherapy under medical supervision and self administered 5% Imiquimod cream   time spot freeze technique will be used for cryotherapy with hand device held perpendicular at a distance of 2 cm from the genital warts until ice formation is there which will be confirmed by palpating it between the fingers. the duration of the freeze cycle will be for 10-20 sec which will be followed by thawing cycle that will be suggested by complete disappearance of frozen white ice. The surrounding area will be protected by liquid paraffin. The timing of the spray will be proportional to the affected area. 5sec for 5cm2 involvement 10sec for 5to 10 cm2 and 20 sec for more than 10cm2 area involvement. Patient will be kept under supervision for three hours and the 5% imiquimod will be applied by the patient himself. followed by alternative regimen of application of imiquimod at night and will be washed off in the morning. Maximum of four cycles of cryotherapy will be given and imiquimod that will be self administered by the patient for a maximum period of 16 weeks at 2 weekly intervals.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Newly diagnosed cases for atleast 3 months duration
Give informed consent
 
 
ExclusionCriteria 
Details  patients having unrealistic expectations or having psychiatric illness
patients with renal, cardiac or hepatic disorders
immunocompromised patients
Pregnancy and lactating mothers  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of cases with complete clearance
Time taken for complete clearance
Mean change in number of lesions
recurrences
adverse events
 		 at baseline at 4 weeks at 8 weeks, 12 weeks and 16 weeks with a follow up period of 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment sessions required for complete clearance of genital warts.
Time taken for complete clearance of genital warts.
Mean change from the baseline
recurrences and
adverse effects
 		 20 weeks
24 weeks
28 weeks
32 weeks post treatment follow up period  
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 3/ Phase 4 
Date of First Enrollment (India)   18/06/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study is an randomized outcome assessor blinded, parallel group Clinical trial comparing the therapeutic efficiency and safety of cryo- podophyllin combination versus cryo-imiquimod combination in the treatment of genital warts in Non-immunocompromised adults for 16 weeks duration in India. The primary outcome measures will be complete clearance of warts, mean change in number of warts and adverse events while secondary outcome measures will be recurrences  at one and three month post treatment.       
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