| CTRI Number |
CTRI/2024/06/068970 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dermoscopy over patch test results |
|
Scientific Title of Study
|
Evaluating the role of dermoscopy for the interpretation of patch test results in suspected cases of Allergic contact dermatitis: A Prospective observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| stutigrawal20 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Stuti Agrawal |
| Designation |
Postgraduate Student |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Department of dermatology, All India Institute Of Medical Science, Bathinda, Punjab, PIN: 151001
Bathinda
PUNJAB
151001
India |
| Phone |
8294183521 |
| Fax |
|
| Email |
stutiagrawalmuz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Bansal |
| Designation |
Assistant Professor and Head |
| Affiliation |
All India Institue Of Medical Science |
| Address |
Department of Dermatology, All India Institue Of Medical Science, Bathinda, Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
8287020404 |
| Fax |
|
| Email |
drshivani.derm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Bansal |
| Designation |
Assistant Professor and Head |
| Affiliation |
All India Institue Of Medical Science |
| Address |
Department of Dermatology, All India Institue Of Medical Science, Bathinda, Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
8287020404 |
| Fax |
|
| Email |
drshivani.derm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Dermatology, All India Institute Of Medical Science, Batinda |
|
|
Primary Sponsor
|
| Name |
All India Institue Of Medical Science Bathinda Punjab |
| Address |
All India Institue Of Medical Science, Jodhpur Ramana, Dabwali road, Bathinda, Punjab, PIN:151001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Stuti Agrawal |
Room No. 2111, Department of dermatology |
All India Institue Of Medical Science, Bathinda
Bathinda
PUNJAB |
8294183521
stutiagrawalmuz@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 |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients age more than 18 years with Allergic Contact Dermatitis.
2.Those patients who developed any type of reaction at patch testing site after 48hrs or 96hrs.
3.Patients who are willing to sign the written consent form before participating in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients having active lesions, significant erythema or scratching over patch test site.
2.Patient with active infection at patch test site.
3.Patient with any active eczema for last 15 days.
4.Those taking oral steroids more than 15 mg prednisolone or any other immunosuppressive, or any form of treatment from last 1 month that known to influence the results of patch test.
5.Application of topical steroid or any topical anti-inflammatory at patch test result site.
6.History of Sunbathing at patch test results site and expose to UVR (Ultra violet radiation) 15 days prior to test.
7.Pregnant females and any immunocompromised patient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| main role of the study is to evaluate the role of dermoscopy for the interpretation of patch test results in patients with suspected case of allergic contact dermatitis. in 72 positive reactions |
It will be evaluate at day 2 and day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| histopathologic correlation |
at day 4 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="1"
Months="6"
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
|
Patients
proforma form will be filled, demographic details will be taken
and patient will be counselled for patch test and for further evaluation. Indian
Standard Series kit from Contact and Occupational Dermatoses Forum of India
CODFI (systopic) will be used.
Informed
Consent will be taken from the patient and the procedure will be explained.
Site selection: Mostly upper back will be preferred, other
sites apart from back is lateral aspect of arms, and hairy area will be
avoided.
Procedure:
1. Site will be cleaned with alcohol swab and
allow it to dry.2 Sheets of patch strip having 10 round aluminum
finn chambers on scanapor in each strip will be taken. 20 antigens with each having
20mg gel antigen or 15µl liquid antigen will be placed over center of finn
chambers on patch strips. After placing antigen, strips will be sticked
over the site using micropore tape firmly and markers will be used to mark the
antigen. First
follow up at 48hrs (Day 2)
After
48 hrs patch strip will be removed and expose tested site to the environment
and marked each tested sites with indelible marker.
After
60 min of exposure, patient will be examined first with naked eyes and if any
positive reaction according to International Contact Dermatits Research Group
(ICDRG)present at any site of patch, hand held dermoscopy both in
polarized and non polarized mode will be used to see the reactions and both clinical and dermoscopic images will be taken.
Patient
will be again explained to avoid bathing and sweating with strenuous exercise
for next 48hrs for second follow up.
Second
follow up at 96 hrs: (Day 4)
Again, after 96hrs, patient is examined first
with naked eyes and if any positive reaction according to ICDRG present at any site of patch, hand held dermoscopy both in polarized and non
polarized mode will be used to see the reactions and both clinical
and dermoscopic images will be taken.
5. |