CTRI

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CTRI Number

CTRI/2025/08/093187 [Registered on: 18/08/2025] Trial Registered Prospectively

Last Modified On:

18/08/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Single Arm Study

Public Title of Study

study of features of warts to predict how well it responds to standard treatment using a special magnifying lens to find signs that show which warts will improve with treatment

Scientific Title of Study

Dermoscopic predictors of treatment response in cutaneous warts: A Prospective Observational Study

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 Niveditha Amarnath
Designation	Junior resident
Affiliation	KASTURBA MEDICAL COLLEGE MANIPAL
Address	Room 22 Department of Dermatology, venereology leprosy OPD Block Manipal academy of higher education Madhav Nagar Manipal Karnataka 576104 Udupi KARNATAKA 576104 India
Phone	9845551450
Fax
Email	niveditha.kmcmpl2024@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Sathish Pai B
Designation	Professor
Affiliation	Kasturba Medical College, Manipal
Address	Room 22 OPD Block Department of Dermatology Venereology and Leprosy Kmc manipal Manipal academy of higher education Manipal karnataka Udupi KARNATAKA 576104 India
Phone	9900405072
Fax
Email	sb.pai@manipal.edu

Details of Contact Person
Public Query

Name	Dr Sathish Pai B
Designation	Professor
Affiliation	Kasturba Medical College, Manipal
Address	Room 22 OPD Block Department of Dermatology Venereology and Leprosy Kmc manipal Manipal academy of higher education Manipal karnataka Udupi KARNATAKA 576104 India
Phone	9900405072
Fax
Email	sb.pai@manipal.edu

Source of Monetary or Material Support

Nil

Primary Sponsor

Name	Self
Address	Room 22 Departmemt of Dermatology Venereology and Leprosy Kmc manipal Manipal academy of higher education Madhav nagar Manipal Karnataka
Type of Sponsor	Other [Self]

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
Dr Niveditha Amarnath	Kasturba Medical College, Manipal	Department of dermatology venereology and Leprosy Room 22 Opd block Udupi KARNATAKA	9845551450 niveditha.kmcmpl2024@learner.manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: B079\|\|Viral wart, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	12.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Newly diagnosed cutaneous warts Age older than 12 Common and plantar warts Undergoing Cryotherapy with parring if required Using Topical keratolytic such as salicylic acid Undergoing immunotherapy such as PPD MMR or vitamin D Combination of these treatments

ExclusionCriteria

Details

Immunosuppressed patient due to HIV cancer or immunosuppressive medications
Lacking initial or follow up clinical and dermoscopic images
Did not complete the planned treatment

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
treatment response to therapy suggested by the clinician, which will be evaluated both clinically and through dermoscopic images	at baseline, and every follow up visit until lesion clearance or 5 follow ups, whichever earlier.

Secondary Outcome

Outcome	TimePoints
how specific dermoscopic features (such as the presence of dots, marked surface scales, and well-defined margins) correlated with these response categories	First visit and every follow up until 5 visits or lesion clearance

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
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)

29/08/2025

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="2"
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

This study aims to determine whether dermoscopic features such as vascular patterns surface scale characteristics and margin definition can predict treatment outcomes in cutaneous warts. The study involves capturing standardized clinical and dermoscopic images before and after treatment including cryotherapy with parring and immunotherapy with intralesional PPD MMR and vitamin D. Topical keratolytic like salicylic acid application in between each of the follow ups will also be included. Each lesions will be followed for five visits or until lesion clearance whichever occurs earlier. Dermoscopic findings will be classified and correlated with treatment response. The objective is to validate dermoscopy as a predictive tool to improve treatment planning and minimize unnecessary sessions. The study addresses the current challenge of variable treatment response and aims to optimize patient care.