| CTRI Number |
CTRI/2025/11/097982 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effectiveness of two ointments, Tacrolimus and Calcipotriol, used along with handheld narrow band UVB light therapy in improving white patches (vitiligo) on the skin.” |
|
Scientific Title of Study
|
Comparision on efficacy of topical Tacrolimus 0 point 1 percent ointment with handheld narrow band ultraviolet B versus topical Calcipotriol 0 point 005 percent ointment with handheld narrow band ultraviolet B in treatment of vitiligo a randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PONNAGANTI PARVATHI ANNAPURNA |
| Designation |
Postgraduate (MD Dermatology, Venereology and Leprosy), 1st Year |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY
SRI DEVARAJ URS MEDICAL COLLEGE
TAMAKA
KOLAR
R.L. Jalappa Hospital and Research Centre,
Tamaka, Kolar – 563101
Kolar
KARNATAKA
563101
India |
| Phone |
8247597977 |
| Fax |
|
| Email |
anuponnaganti9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRMURUGESH SB |
| Designation |
PROFFESOR OF DEPARTMENT OF DERMATOLOGY,SRI DEVARAJ URS MEDICAL COLLEGE |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
SRI DEVARAJ URS MEDICAL COLLEGE
TAMAKA
KOLAR
SRI DEVARAJ URS MEDICAL COLLEGE
TAMAKA
KOLAR
Kolar
KARNATAKA
563101
India |
| Phone |
9880399499 |
| Fax |
|
| Email |
sbmurugesh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PONNAGANTI PARVATHI ANNAPURNA |
| Designation |
Postgraduate (MD Dermatology, Venereology and Leprosy), 1st Year |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY
SRI DEVARAJ URS MEDICAL COLLEGE
TAMAKA
KOLAR
R.L. JALAPPA HOSPITAL AND RESEARCH CENTRE,
TAMAKA, KOLAR – 563101
Kolar
KARNATAKA
563101
India |
| Phone |
8247597977 |
| Fax |
|
| Email |
anuponnaganti9@gmail.com |
|
|
Source of Monetary or Material Support
|
| RL JALAPPA HOSPITAL,SRI DEVARAJ URS MEDICAL COLLEGE,TAMAKA ,KOLAR,563103 |
|
|
Primary Sponsor
|
| Name |
PONNAGANTI PARVATHI ANNAPURNA |
| Address |
DEPARTMENT OF DERMATOLOGY,SRI DEVARAJ URS MEDICAL COLLEGE,TAMAKA,KOLAR,KARNATAKA 563103
|
| Type of Sponsor |
Other [OTHERS ( 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 |
| PONNAGANTI PARVATHI ANNAPURNA |
R.L. JALAPPA HOSPITAL AND RESEARCH CENTRE |
ROOM NO 26, DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY,
SRI DEVARAJ URS MEDICAL COLLEGE,
R.L. JALAPPA HOSPITAL AND RESEARCH CENTRE,
TAMAKA, KOLAR – 563101
Kolar
KARNATAKA |
8247597977
anuponnaganti9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DEVARAJ URS MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical Calcipotriol 0.005 percent ointment with handheld narrow band ultraviolet B |
Participants in Group B will receive topical Calcipotriol 0.005 percent ointment, applied once daily over vitiligo lesions, along with handheld narrow band ultraviolet B (NB-UVB) phototherapy given three times per week.
NB-UVB will start at 200 mJ/cm², increased by 10 percent per session as tolerated, for 3 months.
Follow-up will occur every month, and efficacy will be assessed using VASI and GPA scores. |
| Intervention |
Topical Tacrolimus 0.1 percent ointment with handheld narrow band ultraviolet B |
Participants in Group A will receive topical Tacrolimus 0.1 percent ointment, applied twice daily over vitiligo lesions, along with handheld narrow band ultraviolet B (NB-UVB) phototherapy administered three times per week.
NB-UVB phototherapy will begin at 200 mJ/cm², increased by 10 percent per session as tolerated, for a total duration of 3 months.
Efficacy will be assessed every 2 weeks using the Vitiligo Area Scoring Index (VASI) and Global Photographic Assessment (GPA) scales. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically diagnosed with vitiligo.
Age above six years.
Body surface area involvement less than twenty percent.
Willing to provide written informed consent or assent for minors. |
|
| ExclusionCriteria |
| Details |
Not willing to participate.
Pregnant or lactating women.
Other autoimmune dermatological disorders.
Allergy to tacrolimus or calcipotriol.
Photosensitivity or contraindication to phototherapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the trial is the percentage of repigmentation area in vitiligo patients, which is assessed using the VASI (Vitiligo Area Scoring Index) score |
The outcomes are evaluated at multiple timepoints during the study, but the most specific timepoint of primary interest appears to be the 3 months follow-up after initiating treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Documentation and assessment of adverse effects such as erythema, edema, itching, hypertrichosis, and acne-like papules.Evaluation of improvement by independent, blind third-party assessment using the Global Photographic Assessment (GPA) scale.The mean improvement in the VASI score by the physician (Mean Improvement Score by Physician, MISP). |
3 MONTHS FOLLOW UP |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
03/12/2025 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized controlled trial aimed at comparing the efficacy and safety of topical Tacrolimus 0.1% ointment combined with handheld narrowband ultraviolet B (NBUVB) phototherapy versus topical Calcipotriol 0.005% ointment combined with handheld NBUVB phototherapy in the treatment of vitiligo. The primary purpose is to evaluate which treatment combination offers superior repigmentation and fewer side effects in vitiligo patients. The hypothesis is that both treatment combinations are effective, but the study seeks to determine if one is superior in efficacy and safety profile. The study aims to provide clearer guidance for optimizing clinical management of vitiligo with these topical and phototherapy combinations. |