| CTRI Number |
CTRI/2025/12/098334 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clues to determine the chances of having hairloss in circular patches |
|
Scientific Title of Study
|
Evaluation of Nuclear Factor Erythroid 2-Related Factor 2 (NRF-2) and Total Antioxidant Capacity(TAC) status in patients with Alopecia Areata |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhurima Tadipatri |
| Designation |
Post graduate resident |
| Affiliation |
Father Muller Medical College , Mangalore |
| Address |
Father muller medical college , Father muller road ,Kankanady , Mangalore - 575002
13 , 3RD CROSS , 5TH MAIN , SRINIDHI LAYOUT , KONANAKUNTE , BANGALORE - 560062
Bangalore
KARNATAKA
575002
India |
| Phone |
08884712999 |
| Fax |
|
| Email |
madhurima.0415@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rochelle Monteiro |
| Designation |
Professor |
| Affiliation |
Father Muller Medical College , Mangalore |
| Address |
Father muller medical college , Father muller road ,Kankanady , Mangalore - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9739315324 |
| Fax |
|
| Email |
rochelle.cheryl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhurima Tadipatri |
| Designation |
Post graduate resident |
| Affiliation |
Father Muller Medical College , Mangalore |
| Address |
Father muller medical college , Father muller road ,Kankanady , Mangalore - 575002
13 , 3RD CROSS , 5TH MAIN , SRINIDHI LAYOUT , KONANAKUNTE , BANGALORE - 560062
Bangalore
KARNATAKA
575002
India |
| Phone |
08884712999 |
| Fax |
|
| Email |
madhurima.0415@gmail.com |
|
|
Source of Monetary or Material Support
|
| IADVL Academy Thesis Grant 2025 |
|
|
Primary Sponsor
|
| Name |
IADVL Academy Thesis Grant 2025 |
| Address |
314-315,
3rd Floor KM Trade Tower,
H 3, Sector 14, Kaushambi,
Ghaziabad,Uttar Pradesh. 201010 |
| Type of Sponsor |
Other [ IADVL Academy Thesis Grant 2025 ] |
|
|
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 |
| DrMadhurima tadipatri |
FATHER MULLER MEDICAL COLLEGE |
Number 68 , Dermatology OPD ,FATHER MULLER MEDICAL COLLEGE , FATHER MULLER ROAD , KANKANADY , MANGALORE - 575002
Dakshina Kannada
KARNATAKA |
08884712999
madhurima.0415@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Cases
Clinically diagnosed patients with Alopecia Areata who did not receive any treatment in the last 3 months .
Age 18 to 50 years
Both males and females
Controls
Individuals without alopecia areata and age 18-50 years
|
|
| ExclusionCriteria |
| Details |
Hair regrowth at the time of presentation .
Patients on drugs affecting antioxidant levels like hydroxychloroquine, immunosuppresive drugs ,multivitamins or antioxidants in the last 3 months .
Patients with endocrine and chronic systemic diseases like diabetes mellitus, heart failure, systemic lupus, etc.
Obesity, smoking
Pregnancy, and lactation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of Nuclear factor Erythroid 2-related factor 2 (NRF-2) and Total Antioxidant Capacity (TAC) in Alopecia Areata .
|
18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of NRF-2 and TAC levels in Alopecia Areata and Healthy individuals.
To assess NRF-2 and TAC levels as predictive markers of Alopecia Areata.
Correlation between NRF-2 and TAC with the disease severity and the risk of development of Alopecia Areata .
Clinical and Trichoscopic evaluation of Alopecia Areata.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/10/2026 |
| 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
|
Alopecia areata is an autoimmune condition that
causes hair loss in small, round patches on the scalp or other
areas of the body. While the exact cause
is not fully understood,
genetic and environmental factors
are believed to play a role.
Certain factors like NRF-2 and TAC, are linked to the development of alopecia areata. Evaluating these
biomarkers, comparing their levels between individuals with alopecia areata and
healthy controls, and assessing NRF-2 and TAC as potential predictors of the
condition could be valuable. Additionally, examining the correlation between
NRF-2 and TAC levels with disease severity and the risk of development of alopecia areata, alongside clinical
examination and trichoscopic assessment, may aid in early diagnosis and the exploration of
new treatment possibilities. The promising potential of NRF-2 activators in
addressing oxidative stress-related diseases strongly supports the development
of NRF2- targeted therapies as a novel approach for managing redox-associated
disorders in the hair follicle . |