| CTRI Number |
CTRI/2024/05/067574 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identification of a marker in skin called anti-IgE antibody by microscopy in patients with a blistering disease of skin known as bullous pemphigoid |
|
Scientific Title of Study
|
Detection of anti-IgE antibodies against basement membrane zone in bullous pemphigoid: a cross-sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC2: 154/2024 version 1 dated 30.04.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurodeep Basu |
| Designation |
Academic Junior Resident (MD Dermatology) |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room No. 22
Department of Dermatology,
Kasturba Medical College
MAHE, Manipal
Madhav Nagar,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7753969467 |
| Fax |
|
| Email |
saurodeep97@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghavendra Rao |
| Designation |
Professor, Department of Dermatology |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room No. 21
Department of Dermatology,
Kasturba Medical College
MAHE, Manipal
Madhav Nagar,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9845292640 |
| Fax |
|
| Email |
jenny.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Saurodeep Basu |
| Designation |
Academic Junior Resident (MD Dermatology) |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room No. 22
Department of Dermatology,
Kasturba Medical College
MAHE, Manipal
Madhav Nagar,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7753969467 |
| Fax |
|
| Email |
saurodeep97@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Manipal Academy of Higher Education(MAHE), Manipal,
Madhav Nagar, Udupi,
Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College
MAHE, Manipal
Madhav Nagar,Udupi
Karnataka
Pin - 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Saurodeep Basu |
Room No. 22
Department of Dermatology,
Kasturba Medical College
MAHE, Manipal
Madhav Nagar,Udupi
Karnataka
Pin - 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saurodeep Basu |
Kasturba Medical College Manipal |
Room No. 22
Department of Dermatology,
Kasturba Medical College
MAHE, Manipal
Madhav Nagar,Udupi
Karnataka
Pin - 576104
Udupi
KARNATAKA |
7753969467
saurodeep97@rediffmail.com |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L120||Bullous pemphigoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with a clinical diagnosis consistent with bullous pemphigoid as per the standard diagnostic criteria.
2. Direct immunofluorescence (DIF) microscopy showing linear deposits of IgG and/or Complement C3 along the basement membrane zone.
3. Indirect immunofluorescence (IIF) of salt-split skin biopsy showing deposition of IgG along the basement membrane zone, if done.
|
|
| ExclusionCriteria |
| Details |
1. Severe bleeding and coagulation disorders.
2. Failure to obtain written informed consent for skin biopsy.
3. Severely immunosuppressed conditions, including acquired immunodeficiency syndrome (AIDS).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Demonstration of anti-IgE antibodies in basement membrane zone by direct immunofluorescence (DIF) microscopy |
During hospital stay or on OPD basis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Correlation of anti-BMZ IgE antibodies in skin biopsy with patient characteristics (age, gender, clinical manifestations and duration of the disease)
• Bullous pemphigoid disease area index (BPDAI) score
• Association between anti-BMZ IgE antibodies in skin biopsy with eosinophil and basophil count in the peripheral blood, and serum IgE and IgG (against BP180 and BP230), if done |
During hospital stay or on OPD basis |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
31/05/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [saurodeep97@rediffmail.com].
- For how long will this data be available start date provided 01-09-2027 and end date provided 31-08-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present cross-sectional aims to detect anti-IgE antibodies against BMZ in patients with bullous pemphigoid The primary objective of the study is to demonstrate anti-IgE antibodies in the basement membrane zone by direct immunofluorescence (DIF) microscopy in patients with bullous pemphigoid The secondary objectives of the study are: To demonstrate: • The correlation of anti-BMZ IgE antibodies in skin biopsy with patient characteristics (age, gender, clinical manifestations, and duration of the disease) • Bullous pemphigoid disease area index (BPDAI) score • Association between anti-BMZ IgE antibodies in skin biopsy with eosinophil and basophil count in the peripheral blood and serum IgE and IgG (against BP180 and BP230), if done |