CTRI Number |
CTRI/2021/07/034757 [Registered on: 12/07/2021] Trial Registered Prospectively |
Last Modified On: |
27/12/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Other |
Public Title of Study
|
Correlation of dermatoscopic features of vitiligo with disease activity |
Scientific Title of Study
|
A study to sequentially determine the dermatoscopic features of vitiligo and its correlation with disease activity and treatment response |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Priyansh Gupta |
Designation |
Junior Resident |
Affiliation |
PGIMER Chandigarh |
Address |
694 Sector 11B near architect girls hostel Chandigarh 160011 694 Sector 11B near architect girls hostel Chandigarh 160011 Chandigarh CHANDIGARH 160011 India |
Phone |
7409401008 |
Fax |
|
Email |
priyansh.gupta2412@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vinay K |
Designation |
Assistant Professor |
Affiliation |
PGIMER Chandigarh |
Address |
Department of Dermatology PGIMER Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
8872993222 |
Fax |
|
Email |
vinay.keshavmurthy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vinay K |
Designation |
Assistant Professor |
Affiliation |
PGIMER Chandigarh |
Address |
Department of Dermatology PGIMER Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
8872993222 |
Fax |
|
Email |
vinay.keshavmurthy@gmail.com |
|
Source of Monetary or Material Support
|
Post Graduate Institute of Medical Education and Research Chandigarh 160012 |
|
Primary Sponsor
|
Name |
Department of Dermatology |
Address |
PGIMER Chandigarh |
Type of Sponsor |
Research institution and hospital |
|
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 |
Priyansh Gupta |
PGIMER |
Department of Dermatology PGIMER Chandigarh Chandigarh CHANDIGARH |
7409401008
priyansh.gupta2412@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
PGIMER |
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 |
Not Applicable |
Not Applicable |
Intervention |
Not Applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
1.00 Day(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. A clinical diagnosis of vitiligo (segmental or non-segmental type)
2. Active disease defined as VIDA score of 4+
3. Two independent areas/lesions of of size 2 x 2 cm to 6 x 6 cm showing clinical signs of progressive vitiligo
4. Patients who are yet to be initiated on medical management. A wash off period of 4 weeks for topical and 12 weeks for systemic treatment will be ensured. |
|
ExclusionCriteria |
Details |
1. Stable disease
2. Patients with only mucosal vitiligo
3. Patients receiving phototherapy or surgical management
4. Patients who refuse to give consent for participation in the study |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To sequentially determine the dermatoscopic features of vitiligo |
Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To correlate the dermatoscopic features with disease activity assessed by means of VIDA and VASI.
2. To correlate the dermatoscopic features of repigmentation with treatment modality used. |
4 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/07/2021 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Vitiligo is one of the common acquired pigmentary disorders, which is characterized by depigmentation as a result of the loss of melanin producing cells also known as melanocytes. The prevalence rate of vitiligo in the world approximates around 1%, while in India it goes up to 8.8%, making it a significant proportion of patients seen in dermatology services. The dark complexion of ethnic skin combined with social stigma and lack of knowledge about the disease in the general population causes a lot of psychological distress to affected patients. Vitiligo is characterized by milky or ivory white sharply demarcated macules, often symmetrical on both sides of the body. The size of the lesions may vary from a few millimetres to several centimetres. The most common sites affected are the ones which are prone to repeated trauma or chronic pressure or friction like hips, dorsum of hands and feet, ankles, elbows and knees. The natural course of the disease is highly unpredictable as well, with periods of abrupt onset, active disease, then stability or repigmentation and rapid progression after a period of dormancy. There are many theories and hypothesis suggesting the pathophysiology of vitiligo: genetic, biochemical, neural, autoimmune, defective free radical defence, etc. In spite of this, vitiligo still remains an idiopathic disorder, with more than one factor at play in a single individual. Conventional medical therapies have used both topical and oral treatment. First line therapies are usually topical steroids or topical calcineurin inhibitors like tacrolimus.3 Oral mini pulse therapy using dexamethasone is used for rapidly progressive or active disease and has shown to halt the disease activity and caused repigmentation in some patients.3 Other therapies like antioxidants, systemic phototherapy i.e. psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) therapy, laser therapy are also being used. Surgery as a therapeutic option is kept for patients who have stable disease and are not responding to medical therapies. This mostly includes autologous grafting techniques, both tissue and cellular (both cultured and non-cultured). |