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CTRI Number  CTRI/2026/01/102139 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 24/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A Study on the effectiveness and adverse effect profile among patients treated with autoinoculation for multiple viral warts. 
Scientific Title of Study   A Study on the effectiveness and adverse effect profile among patients treated with autoinoculation for multiple viral 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  Ashwini B 
Designation  Associate Professor 
Affiliation  Associate Professor 
Address  Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum
Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum
Thiruvananthapuram
KERALA
695028
India 
Phone  9986410636  
Fax    
Email  ashwinibabu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ASHWINI B 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SREE UTHRADOM THIRUNAL ACADEMY OF MEDICAL SCIENCES 
Address  Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum
Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum
Thiruvananthapuram
KERALA
695028
India 
Phone  9986410636  
Fax    
Email  ashwinibabu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ASHWINI B 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SREE UTHRADOM THIRUNAL ACADEMY OF MEDICAL SCIENCES 
Address  Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum
Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum
Thiruvananthapuram
KERALA
695028
India 
Phone  9986410636  
Fax    
Email  ashwinibabu@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Ashwini B 
Address  Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ashwini B  Sree Uthradom Thirunal Academy Of Medical Sciences   Department of Dermatology Venereology and Leprosy Sree Uthradom Thirunal Academy Of Medical Sciences Vencode Trivandrum
Thiruvananthapuram
KERALA 
9986410636

ashwinibabu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee(SUTAMS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: B079||Viral wart, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autoinoculation for 1 year  autoinoculation of viral wart to non dominant arm, into a subdermal pocket to mount an immune response and observed after 4 weeks and 12 weeks 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
All diagnosed cases of warts more than five in number
Patients with naive or recurrent or treatment unresponsive warts
Patients willing to undergo the procedure of autoinoculation
 
 
ExclusionCriteria 
Details  Pregnancy and lactating mothers
Patients with bleeding diathesis
Patients with serious systemic illness
Immunocompromised patients due to disease or drugs
Patients who are not mentally fit so as to understand the nature of procedure and possible adverse effects.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To describe and determine the effectiveness of autoinoculation for the treatment of multiple viral warts at a tertiary health care center at 4 weeks and 12 weeks
 
To describe and determine the effectiveness of autoinoculation for the treatment of multiple viral warts at a tertiary health care center at 4 weeks and 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To describe & determine the adverse effects of autoinoculation for the treatment of multiple viral warts at a tertiary health care center at 4 weeks & 12 weeks
 
To describe & determine the adverse effects of autoinoculation for the treatment of multiple viral warts at a tertiary health care center at 4 weeks & 12 weeks
 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 2 
Date of First Enrollment (India)   06/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/02/2026 
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  

Warts are papillomatous benign skin outgrowths arising from the epidermis as a result of an infection by human papilloma virus .1 Clinical manifestatations could range from asymptomatic papules, plaques with verrucous surface, pruritis , painful plaques involving any part of skin, mucocutaneous or mucosal tissue leading to cosmetic disfigurement and morbidity with atendency to spread contiguously and distally.2   Depending on the number and site of warts a wide plethora of treatment options are available including topical keratolytics like salicyclic acid, topical podophyllin, imiquimod application, topical sensitizers like dinitrochlorobenzene(DNCB), squaric acid dibutyl ester( SADBE),  radiofrequency monopolar ablation, cryotherapy, ablative CO2 laser, intalesional MMR, intralesional bleomycin. 1 Treatment with the above modalities poses a challenge when warts are multiple in number,

 refractory to treatment and recurs following treatment, painful wounds

 following electrosurgical or destructive procedures especially when multiple or is located at a site difficult to treat such as over eyelids, peri or subungual area. 1 

There is a need for a treatment procedure that involves minimal sittings and is practically simple to perform with minimal wounds, this lead to the development of autoinoculation as a procedure to treat multiple and recurrent warts.

Since the procedure involves a surgical procedure that is being increasingly utilized one is bound to encounter adverse effects both minor and major and a study of the side effects encountered is warranted to examine its potential as an effective treatment modality for viral warts.

       Patients diagnosed with viral warts between December 2025 to November 2026 attending the Dermatology OPD will be recruited in this study with a minimum sample size of 29 patients.

           Characteristics such as age, sex and duration of warts, any previous administered treatment, history of recurrence is noted, presenting features such as history of itching, pain are noted.

       Examination findings such as clinical morphology and site of warts is noted. Number of warts and percentage decline is noted at the end of 1st and 3rd month.

       Autoinoculation procedure is performed as follows:

       After obtaining informed written consent and obtaining photographs of warts at baseline, routine investigations are done such as complete blood count, random blood sugar, tests for HBsAg, HIV, HCV and other investigations as indicated. Those unvaccinated were administered the tetanus toxoid vaccine prior to procedure. Test dose for 2% lignocaine is administered.

       The older onset warts are preferred for donor site.

       Procedure followed is as per description by Lal NR et al3 with minor modifications.

Under sterile aseptic precautions the selected donor wart after administering 2% lignocaine is shave excised using number 15 surgical scalpel blade. The donor site hemostasis is ensured with the coagulation mode of a radiofrequency monopolar

        probe. 

       The wart tissue excised is cut into small bits using the scalpel blade, the ventral surface is examined for a white surface which is indicative of wart material and placed in a sterile bowl with normal saline.

       Recipient area is chosen over the ventromedial aspect of the non-dominant arm, palpated to ensure no underlying pulsation and a nick 3 mm long after ensuring asepsis is made using a fresh sterile number 15 surgical blade. Tissue to the medial aspect of this incision is dissected using blunt curved artery forceps to create a subdermal pocket where the wart material obtained is placed and the skin is sutured using 3-0 non absorbable suture material. Hemostasis is ensured and the donor and recipient sites are dressed with topical mupirocin. The patient is given 5 days of oral amoxcillin and clavulanic acid and anti-inflammatory agent in case of pain. Patients were instructed to keep the dressing till 3 days following which it can be changed at a local hospital once in 2 days and to review after 10 days for suture removal.

       Patients were then asked to follow up after 1 month and 3 months and examined for number of warts and percentage reduction and quantified as <25%, 26-50%, 51 -75% and >75 % improvement if any, worsening or no improvement was also noted. Patients were asked for immediate side effects such as pain, bleeding after 10 days , delayed changes such as secondary infection, contact dermatitis, hyperpigmentation and  new wart at autoinoculation site, side effects at the donor site included hypopigmentation and scarring if any at the end of 1st and 3rd month.

       probe. 

       The wart tissue excised is cut into small bits using the scalpel blade, the ventral surface is examined for a white surface which is indicative of wart material and placed in a sterile bowl with normal saline.

       Recipient area is chosen over the ventromedial aspect of the non-dominant arm, palpated to ensure no underlying pulsation and a nick 3 mm long after ensuring asepsis is made using a fresh sterile number 15 surgical blade. Tissue to the medial aspect of this incision is dissected using blunt curved artery forceps to create a subdermal pocket where the wart material obtained is placed and the skin is sutured using 3-0 non absorbable suture material. Hemostasis is ensured and the donor and recipient sites are dressed with topical mupirocin. The patient is given 5 days of oral amoxcillin and clavulanic acid and anti-inflammatory agent in case of pain. Patients were instructed to keep the dressing till 3 days following which it can be changed at a local hospital once in 2 days and to review after 10 days for suture removal.

       Patients were then asked to follow up after 1 month and 3 months and examined for number of warts and percentage reduction and quantified as <25%, 26-50%, 51 -75% and >75 % improvement if any, worsening or no improvement was also noted. Patients were asked for immediate side effects such as pain, bleeding after 10 days , delayed changes such as secondary infection, contact dermatitis, hyperpigmentation and  new wart at autoinoculation site, side effects at the donor site included hypopigmentation and scarring if any at the end of 1st and 3rd month.

 
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