| CTRI Number |
CTRI/2025/07/091990 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of dermoscopy in interpreting results of Patch Test in patients- a hospital study |
|
Scientific Title of Study
|
Role of dermoscopy in interpreting results of patch test - a hospital 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 Subhashini |
| Designation |
Junior resident |
| Affiliation |
Shriram Murti smarak institute medical bareilly |
| Address |
Department of dermatology room 4 Shri Ram murti smarak institute of medical sciences
Department of dermatology room 4 Shri Ram murti smarak institute of medical sciences
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6386594424 |
| Fax |
|
| Email |
paoshverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhur kant Rastogi |
| Designation |
Professor |
| Affiliation |
Shri ram Murti smarak institute medical bareilly |
| Address |
Dermatology department room 4 Shri Ram murti smarak bhojipira Bareilly
Dermatology department room 4 Shri Ram murti smarak bhojipira Bareilly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9808158474 |
| Fax |
|
| Email |
kantmadhur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhashini Yadav |
| Designation |
Junior Resident |
| Affiliation |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Dermatology department room 4 Shri Ram murti smarak bhojipira Bareilly
Dermatology department room 4 Shri Ram murti smarak bhojipira Bareilly
Bareilly
UTTAR PRADESH
226003
India |
| Phone |
6386594424 |
| Fax |
|
| Email |
paoshverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Subhashini
Srms bhojipura
bareilly
Uttar Pradesh 243202
India |
|
|
Primary Sponsor
|
| Name |
Dr Subhashini |
| Address |
Shri ram murti smarak institute of medical sciences Bareilly 243202 India |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shriram Murti smarak institute medical bareilly |
Shriram Murti smarak institute medical, bhojipura bareilly |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhashini Yadav |
SRMS IMS MEDICAL COLLEGE |
Shri ram Murti smarak institute medical sciences bhojipura, bareilly 243202
Bareilly
UTTAR PRADESH |
6386594424
paoshverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from allergic contact dermatitis |
|
| ExclusionCriteria |
| Details |
Patients suffering from any other active skin disease
Patients on corticosteroid more than or equal 15 mg or using topical steroids at site of applications of Patch test
Pregnancy
Lactating patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Findings in dermoscopy correlating with positive patch test result of a certain allergen |
At 48 hours post patch test application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patch testing will be done in patients with allergic contact dermatitis and results on naked eye observation and dermoscopic changes will be compared at after 24 hours. Dermoscopy is an non-invasive and safe method in monitoring various types of skin changes which are not visible to naked eyes. |