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CTRI Number  CTRI/2020/02/023495 [Registered on: 21/02/2020] Trial Registered Prospectively
Last Modified On: 20/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study of effectiveness and side effects of light therapy with oral medication called "Khellin" in Vitiligo patients. 
Scientific Title of Study   A prospective observational study on the efficacy and side effects of oral KUVA ( khellin UV A) SOL therapy in stable vitiligo patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not Aplicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lavin Bhatia 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal Academy of Higher Education 
Address  Skin Opd, Room number 21, Department of Dermatology, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  8369098740  
Fax    
Email  bhatialavin700@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sathish Pai B 
Designation  Professor and Head of Unit, Department of Dermatology 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal Academy of Higher Education 
Address  Department of Dermatology, Skin OPD, Room number 21, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  drsbpai@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sathish Pai B 
Designation  Professor and Head of Unit, Department of Dermatology 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal Academy of Higher Education 
Address  Department of Dermatology, SKIN OPD, Room 21, Kasturba Hospital, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  drsbpai@yahoo.co.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Lavin Bhatia 
Address  OPD 21 Kasturba Hospital Manipal. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR LAVIN BHATIA  KASTURBA HOSPITAL, Manipal  Skin Opd, Room number 21, Department of Dermatology, KASTURBA HOSPITAL AND KASTURBA MEDICAL COLLEGE, MANIPAL, UDUPI, 576104
Udupi
KARNATAKA 		 8369098740

bhatialavin700@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with stable lesions.
2.Patients between 18 and 60 years of age.
3.Patients who give informed consent for the study and photography.
4.Patients who can follow up in the opd
 
 
ExclusionCriteria 
Details  1.Patients who are unwilling to participate in the study.
2.Patients who had used any topical treatment 2 weeks and systemic treatment 4 weeks before starting on KUVA SOL.
3.Patients with history of photosensitive disorders, skin cancer, hepatic or renal disease and lesions over genitals.
4.Pregnant or lactating women.
5.Unstable vitiligo.
6.Patients with spontaneous repigmentation of depigmented macules.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.VASI ( Vitiligo Area Scoring Index)
2.VIDA ( Vitiligo Disease Activity)
3.VAS ( Visual Analogue Scale)
4.Scoring by Dermosopy Image Processing Methodology.
5. Side Effects.
 		 Every 4 weeks of initiating therapy for total of 16 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Liver function tests.
2. Renal function tests.
3. complete blood count.
 		 0, 8 weeks, 16weeks. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/02/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.Hofer A1, Kerl H, Wolf P. "Long-term results in the treatment of vitiligo with oral khellin plus UVA." Eur J Dermatol. 2001 May-Jun;11(3):225-9 2.Ortel b, tanew a, hönigsmann h. "treatment of vitiligo with Khellin and ultraviolet a." j am acad dermatol. 1988 apr;18(4 pt 1):693-701 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Vitiligo is an acquired condition resulting in loss of melanocytes causing localized depigmentation affecting 0.5 – 1% of the world’s population. Although it is not a life-threatening condition but it causes severe disfiguration and considerable emotional and social distress. Both local and systemic PUVA therapies remain first-line methods for treating the disease. However, side effects like nausea, headache, vomiting, increased liver transaminases, severe photo-toxic reactions are common in systemic PUVA treatment. These side effects justify the research for photochemotherapeutic agent like Khellin with possible less side effects and potentially same efficacy. In this study, we focus on adding information to the literature about efficacy and adverse effects of KUVA - SOL therapy ( Khellin UV-A SOL) which is a ptomising treatment option for vitiligo. The study will recruit patients who are to be initiated on KUVA SOL therapy coming to Kasturba Hospital, Manipal SKIN OPD. 
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