| CTRI Number |
CTRI/2026/04/107307 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking patterns on hair and skin smear to find pemphigus vulgaris early. |
|
Scientific Title of Study
|
Direct immunofluroscence pattern on plucked hair and tzanck smear in pemphigus vulgaris cases. |
| 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 Rashmi |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical college |
| Address |
Room no. 54 Department of pathology ,pathology block , Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg Central
Room no. 212 Department of pathology ,pathology block , Maulana Azad Medical College, Central delhi
Central
DELHI
110002
India |
| Phone |
9821987316 |
| Fax |
|
| Email |
rashmimeenu666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meeta Singh |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical college |
| Address |
Room no. 54 Department of pathology ,pathology block , Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg Central
Room no. 56 Department of pathology ,pathology block , Maulana Azad Medical College, Central delhi
Central
DELHI
110002
India |
| Phone |
9968604327 |
| Fax |
|
| Email |
meetamamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical college |
| Address |
Room no. 54 Department of pathology ,pathology block , Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg Central
Room no. 62 Department of pathology ,pathology block , Maulana Azad Medical College, Central delhi
Central
DELHI
110002
India |
| Phone |
9821987316 |
| Fax |
|
| Email |
rashmimeenu666@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college, 2 bahadur shah zafar marg, new delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New
Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Rashmi |
Maulana Azad Medical College |
Room no. 54 Department of pathology ,pathology block , Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg Central
Room no. 54 Department of pathology ,pathology block , Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg Central
Central
DELHI |
09821987316
rashmimeenu666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L100||Pemphigus vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed case of pemphigus vulgaris. |
|
| ExclusionCriteria |
| Details |
Inadequate biopsy sample and extremely sick patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patterns of DIF on tzanck smear and plucked hair in diagnosis of Pemphigus vulgaris. |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of DIF pattern on Tzanck smear and plucked hair with biopsy. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/04/2026 |
| 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="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
|
Pemphigus vulgaris is an autoimmune vesiculobullous disorder characterized by flaccid blisters and erosions of the skin and mucous membranes caused by autoantibodies directed against desmoglein 1 and 3. Diagnosis is confirmed by histopathology and direct immunofluorescence (DIF) of perilesional skin biopsy, which shows intercellular deposits of IgG and C3 in a fish-net pattern. However, skin biopsy requires invasive sampling and special laboratory facilities, which may not always be feasible.
This study aims to evaluate the diagnostic utility of DIF on Tzanck smear and plucked hair as less invasive alternatives to skin biopsy in pemphigus vulgaris. Tzanck smear involves scraping the base of a vesicle, while plucked hair DIF examines the outer root sheath for intercellular IgG and C3 deposits. The results of these tests will be compared with the gold standard DIF on skin biopsy to assess their sensitivity and specificity.
A cross-sectional observational study will be conducted on clinically and histologically confirmed cases at Maulana Azad Medical College, New Delhi. This research may help establish simple, rapid, and cost-effective diagnostic tools for pemphigus vulgaris, especially useful in patients where biopsy is difficult or contraindicated. |