| CTRI Number |
CTRI/2024/05/067554 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Psychological Impact, associated disorders and Treatment for Vitiligo
|
|
Scientific Title of Study
|
To Study the Psychological Impact, Associated Disorders and Treatment Options in Vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zahid Ashraf |
| Designation |
PG Student |
| Affiliation |
Department of Pharmaceutical Sciences, University of Kashmir |
| Address |
Room No. 1 , building No. 4, Dept of Ph. Sciences,UOK Hazratbal, Srinagar 190006
Room No. 3 , building No. 4, Dept of Ph. Sciences,UOK Hazratbal, Srinagar 190006
Srinagar
JAMMU & KASHMIR
193201
India |
| Phone |
7006980948 |
| Fax |
|
| Email |
zahid.ashraf.942@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zahid Ashraf |
| Designation |
PG Student |
| Affiliation |
Department of Pharmaceutical Sciences, University of Kashmir |
| Address |
Room No. 1 , building No. 4, Dept of Ph. Sciences,UOK Hazratbal, Srinagar 190006
Room No. 3 , building No. 4, Dept of Ph. Sciences,UOK Hazratbal, Srinagar 190006
Srinagar
JAMMU & KASHMIR
193201
India |
| Phone |
7006980948 |
| Fax |
|
| Email |
zahid.ashraf.942@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GN Bader |
| Designation |
Senior Assistant Professor |
| Affiliation |
Department of Pharmaceutical Sciences, University of Kashmir |
| Address |
Room No. 2 , building No. 4, Dept of Ph. Sciences,UOK Hazratbal, Srinagar 190006
Room No. 3 , building No. 4, Dept of Ph. Sciences,UOK Hazratbal, Srinagar 190006
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006224042 |
| Fax |
|
| Email |
gnbader@kashmiruniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Venereology & Leprosy GMC, Baramulla , 193103 |
| Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal Srinagar 190006 |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology Government Medical College Baramulla |
| Address |
E3 OPD Department of Dermatology, Government Medical College, Kanthbagh Baramulla,193103 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Pharmaceutical Sciences University of Kashmir |
Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal Srinagar 190006 |
| Dr GN Bader |
Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal Srinagar 190006 |
| Dr Parvaiz Anwar Rather |
Baramulla |
| Zahid Ashraf |
H-92 Shalimar Colony Sopore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parvaiz Anwar Rather |
Room E3 1st floor block E, F & G, Dept. of Dermatology GMC Kanthbagh Baramulla, 193103 |
Room E3 First floor block E,F and G Department of Dermatology Government Medical College Kanthbagh Baramulla, 193103
Baramula
JAMMU & KASHMIR |
9419129334
parvaizanwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College Baramulla Institutional Review Board |
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
1. All the patients diagnosed with Vitiligo of all age groups and of either sex visiting OPD of the Dermatology Department and who gave consent during the study period were included in this study.
2. Confirmed vitiligo diagnosis by a healthcare professional through clinical examination, dermoscopy, or biopsy (specific methodology may vary based on study design).
3. Consent to participate in the study procedures, including surveys, interviews, physical examinations, blood tests, or imaging studies (specific procedures depend on study focus).
4. No age or demographic restrictions unless studying specific populations (e.g., pregnant women, above 70 years).
5. Age of consent (e.g., 18+) and ability to complete psychological assessments.
6. Diagnosis of a specific co-occurring disorder confirmed through medical records or additional diagnostic procedures.
7. Specific disease type, severity, and age range suitable for the investigated treatment modality.
|
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent to participate in the study.
2. Mimicking Conditions: Presence of skin conditions that could mimic vitiligo (e.g., piebaldism, post-inflammatory hypopigmentation).
3. Self-Reported Vitiligo: Individuals lacking a professional diagnosis of vitiligo.
4. Cognitive/Psychiatric Conditions: Severe cognitive or psychiatric conditions that could significantly impact data collection or interpretation.
5. Medical Conditions: Presence of medical conditions that could confound study results or pose safety risks (e.g., chronic infections, certain medications).
6. Treatment Contraindications: Known contraindications to the specific treatment being investigated (e.g., allergies, specific medical conditions).
7. Ongoing Trials: Participation in other clinical trials that could interfere with study results.
8. Individuals with language barriers that impede effective communication may be excluded.
9. Pregnant or breastfeeding women may be excluded depending on the specific treatment safety data.
10. Uncertain diagnoses of vitiligo or co-occurring disorders may lead to exclusion to ensure study accuracy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved diagnosis and management strategies for healthcare professionals dealing with Vitiligo patients.
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhanced psychological support and interventions to address the emotional and social impact of Vitiligo. |
6 months |
| Identification of potential Comorbidities and associated disorders to guide comprehensive patient care. |
6 months |
Evaluation of treatment options to determine their effectiveness, patient satisfaction, and areas for improvement.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
01/06/2024 |
| 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="0"
Months="6"
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
|
Scope This thesis will focus on the investigation of clinical and genetic features of vitiligo patients and the evaluation of different treatment modalities, using a combination of cross-sectional and longitudinal study designs. The study will be conducted in the Department of Dermatology, Venereology & Leprosy GMC, Baramulla, and will include patients with different clinical subtypes and severity of vitiligo. This research focuses on a specific geographic region and aims to provide recent and relevant data regarding the prevalence, psychological impact, associated disorders, and treatment options for Vitiligo. This research covers recent developments in the study of Vitiligo, encompassing epidemiology, psychological aspects, comorbidities, and emerging treatments. We focus on recent data to ensure the most current understanding of the condition. Hypotheses Vitiligo has a negative impact on self-esteem and quality of life. There is an association between Vitiligo and autoimmune disorders. Emerging therapies, such as JAK inhibitors, show promise in the treatment of Vitiligo. Recent epidemiological studies suggest that regions with higher exposure to ultraviolet (UV) radiation have a higher prevalence of Vitiligo. Recent psychological assessments indicate that individuals with Vitiligo experience lower self-esteem and quality of life compared to those without the condition. Recent research suggests that support from friends and family, along with professional therapy, positively impacts the psychological well-being of Vitiligo patients. Recent correlation analyses indicate a strong link between the severity of Vitiligo and the presence of autoimmune co morbidities. Recent clinical trials highlight the promising potential of emerging therapies like JAK inhibitors in regimenting Vitiligo patches. |