| CTRI Number |
CTRI/2025/09/094761 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying whether a simple skin test can show how well vitiligo improves with light therapy |
|
Scientific Title of Study
|
An observational study to assess utility of dermoscopy as a clinical response predictor in non-segmental vitiligo treated with narrow band ultraviolet B phototherapy, SMS medical college, Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANSHRUTA TEOTIA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sawai Man Singh Medical College and hospitals |
| Address |
21 The Green Rajokri
South West DELHI 110038 India |
| Phone |
9810408895 |
| Fax |
|
| Email |
anshruta.teotia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ram Singh Meena |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and hospitals |
| Address |
D-272, Bypass, Siddharth Nagar, Malviya Nagar, Jaipur, Rajasthan
Jaipur RAJASTHAN 302017 India |
| Phone |
9829177003 |
| Fax |
|
| Email |
dr.ramsinghmeena@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ram Singh Meena |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and hospitals |
| Address |
D-272, Bypass, Siddharth Nagar, Malviya Nagar, Jaipur, Rajasthan
RAJASTHAN 302017 India |
| Phone |
9829177003 |
| Fax |
|
| Email |
dr.ramsinghmeena@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical College and attached hospitals, Gangwal park adarsh nagar jaipur, Rajasthan. India 302004 |
|
|
Primary Sponsor
|
| Name |
ANSHRUTA TEOTIA |
| Address |
21 The Green Rajojri New Delhi 110038 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Anshruta Teotia |
SMS Medical College and Attached Hospitals |
Charak Bhawan Room No. 23 Department of Dermatology, Venereology & Leprosy, SMS Medical College and Attached Hospitals,Gangwal Park, Adarsh nagar, Jaipur, Rajasthan, India – 302004 Jaipur RAJASTHAN |
9810408895
anshruta.teotia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical college and attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinically diagnosed non-segmental vitiligo.
Presence of at least 3 vitiligo patches scheduled for NB-UVB phototherapy.
One acral (hands/feet/bony prominence) and one non-acral lesion will be selected whenever feasible.
Patient provides written informed consent |
|
| ExclusionCriteria |
| Details |
Patients who used systemic or topical medications for vitiligo in the past 4 weeks or receiving surgical treatment.
Patients with other significant dermatoses.
Pregnant or breastfeeding women.
Patients with history of photosensitizing disorders, sensitivity to phototherapy, or claustrophobia.
Uncooperative or unwilling participants. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Vitiligo Area Scoring Index (VASI) after NB-UVB phototherapy, and correlation of dermoscopic findings with this change in patients with non-segmental vitiligo. |
Baseline (before starting NB-UVB)
4 weeks of treatment
8 weeks of treatment
12 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Correlation of specific dermoscopic patterns (e.g., perifollicular repigmentation, pigment network) with extent of clinical improvement.
2)Access Safety/tolerability of NB-UVB |
Baseline (before starting NB-UVB)
4 weeks of treatment
8 weeks of treatment
12 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/10/2025 |
| 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
|
Vitiligo is a common skin disorder characterized by loss of pigmentation, which can significantly affect the quality of life of patients. Narrow band ultraviolet B (NB-UVB) phototherapy is a standard and widely used treatment for non-segmental vitiligo. However, the degree of clinical improvement varies among patients, and there is a need to identify early predictors of response to guide management. Dermoscopy is a non-invasive tool that allows detailed visualization of skin structures not visible to the naked eye. Certain dermoscopic features may provide valuable information about disease activity and potential for repigmentation. The present study is a prospective observational study being conducted in the Department of Dermatology, SMS Medical College, Jaipur. Patients with non-segmental vitiligo who are scheduled to undergo NB-UVB phototherapy and meet inclusion criteria will be enrolled after providing informed consent. Baseline dermoscopic findings of selected vitiligo patches (acral and non-acral sites whenever feasible) will be recorded. Patients will then undergo NB-UVB phototherapy for 12 weeks. Changes in vitiligo lesions will be assessed clinically using the Vitiligo Area Scoring Index (VASI), and correlated with baseline dermoscopic findings to evaluate their predictive value. The primary outcome is to determine whether specific dermoscopic features can serve as predictors of clinical improvement in vitiligo patients receiving NB-UVB therapy. This may help in better counseling, early identification of likely responders, and optimizing treatment decisions in vitiligo management. |