| CTRI Number |
CTRI/2023/07/055462 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational real world study |
| Study Design |
Other |
|
Public Title of Study
|
An Immuno-Dermatological disease registry in Indian Patients |
|
Scientific Title of Study
|
An Immuno-Dermatological disease registry to understand the burden of Atopic dermatitis (AD), Alopecia areata (AA), and Vitiligo in Indian Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesha Bhat |
| Designation |
Vice Dean |
| Affiliation |
Father Muller Medical College, Kankanady |
| Address |
Father Muller Medical College and Hospital,
I(ankanady,
Mangalore - 575 002
Bangalore
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
rameshderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Karekar |
| Designation |
Medical Advisor |
| Affiliation |
Inflammation & Immunology Medical Affairs, Pfizer India |
| Address |
The Capital,18th & 19th Floor, Plot No. C-70, G. Block, Bandra Kurla ComplexBandra (E) Mumbai – 400051
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
Sonali.Karekar@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charles Adhav |
| Designation |
Medical Lead |
| Affiliation |
Inflammation & Immunology Medical Affairs, Pfizer India |
| Address |
The Capital,18th & 19th Floor, Plot No. C-70, G. Block, Bandra Kurla ComplexBandra (E) Mumbai
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
Charles.Adhav@pfizer.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pfizer Ltd |
| Address |
Street: 1802 18th Floor Plot No C-70, G Block Bandra
City: East Mumbai
State: N/A ZIP Code 400051
Country: India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran Godse |
DY Patil Hospital |
5th Floor,Medical college building,
Ayyappa Rd,Dr D Y Patil Vidyanagar,Sector 5,Nerul
Thane
MAHARASHTRA |
9322266687
drgodse@hotmail.com |
| Dr Ramesha Bhat |
Father Muller Medical College and Hospital |
VV86 CWM Father Mullers Rd Kankanady Mangaluru Karnataka
Dakshina Kannada
KARNATAKA |
9845084224
rameshderma@gmail.com |
| Dr Abir Saraswat |
Indushree Skin Clinic |
B-7,Faizabad Rd,near hotel bandhan, Sector 5,Indira Nagar, Lucknow,Uttar Pradesh 226016
Lucknow
UTTAR PRADESH |
9415256229
abirsaraswat@yahoo.com |
| Dr Abhishek De |
Wizderm Specialty Skin And Hair Clinic |
1st floor Onex Square, 75, Shakespeare sarani Rd, Kolkata, West Bengal-700017
Kolkata
WEST BENGAL |
9903275551
dr_abhishek_de@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
| Gurushree Hi-Tech Multispecialty Hospital |
Approved |
| Gurushree Hi-Tech Multispecialty Hospital |
Approved |
| Institutional Ethics Committee D Y Patil Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20||Atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. Be aged between 2 and 64 years old.
2. Clinical diagnosis of Vitiligo, AA or AD.
3. Evidence of a personally signed and dated informed consent/assent document
indicating that the patient (or a legally acceptable representative) has been informed
of all pertinent aspects of the study. |
|
| ExclusionCriteria |
| Details |
Patients meeting any of the following criteria will not be included in the study:
1. Not willing to provide written informed consent.
2. Not willing for a follow-up visit. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the epidemiological burden of mild, moderate and severe AD,vitiligo,and AA across enrolled dermatology centers |
followup visits take place at intervals at the investigators discretion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To elucidate the current diagnostic criteria and grading modalities for AD,vitiligo,and AA in India. |
followup visits take place at intervals at the investigators discretion. |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
31/07/2023 |
| 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="3"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of this registry is to evaluate the epidemiological burden of mild, moderate and severe AD, vitiligo, and AA across enrolled dermatology centers. Elucidate the current diagnostic criteria and grading modalities for AD, vitiligo, and AA in India. There is no study-related intervention.
|