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CTRI Number  CTRI/2015/11/006363 [Registered on: 17/11/2015] Trial Registered Retrospectively
Last Modified On: 20/10/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [NARROW BAND ULTRA VIOLET B ( NBUVB ) PHOTOTHERAPY AND TOPICAL CALCIPOTRIOL OINTMENT ( 0.005% )]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison Study of Two Treatment Modalities i.e. Calcipotriol Ointment and Calcipotriol Ointment Along With Ultraviolet Phototherapy in Special Kind of Hairloss Disorder Called as Alopecia Areata 
Scientific Title of Study   A Randomised Comparative Study of Topical Calcipotriol (0.005%) Vs Topical Calcipotriol (0.005%) along with NBUVB Phototherapy in Patients of Alopecia Areata  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHANDRA SHEKHAR JAISWAL 
Designation  RESIDENT DOCTOR 
Affiliation  Dept. of Skin & V.D. 
Address  OPD No 115, New OPD building Sir T hospital
OPD No 115, New OPD building Sir T hospital
Bhavnagar
GUJARAT
364001
India 
Phone  9425328682  
Fax    
Email  shekhar_innn@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR HITA H MEHTA 
Designation  PROFESSOR 
Affiliation  Dept. of Skin & V.D. 
Address  OPD No 115, New OPD building Sir T hospital
OPD No 115, New OPD building Sir T hospital
Bhavnagar
GUJARAT
364001
India 
Phone  9429503188  
Fax    
Email  hitamehta88@gmail.com  
 
Details of Contact Person
Public Query  
Name  CHANDRA SHEKHAR JAISWAL 
Designation  RESIDENT DOCTOR 
Affiliation  Dept. of Skin & V.D. 
Address  OPD No 115, New OPD building Sir T hospital
OPD No 115, New OPD building Sir T hospital
Bhavnagar
GUJARAT
364001
India 
Phone  9425328682  
Fax    
Email  shekhar_innn@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Medical College & Sir Takhtsinhji Hospital, Bhavnagar  
 
Primary Sponsor  
Name  DEPARTMENT OF SKIN AND VD 
Address  DEPARTMENT OF SKIN AND VD SIR T HOSPITAL JAIL ROAD BHAVNAGAR GUJARAT 364001 
Type of Sponsor  Government medical college 
 
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 
CHANDRA SHEKHAR JAISWAL  Government Medical College & Sir T Hospital  jail road
Bhavnagar
GUJARAT 		 9425328682

shekhar_innn@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Government Medical College, Bhavnagar, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS OF ALOPECIA AREATA WITH GOOD GENERAL CONDITION AND FREE FROM ANY MAJOR SYSTEMIC ILLNESS.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical calcipotriol (0.005%) ointment  It is a vitamin D analogue. It has therapeutic effect in various immune mediated disorders including alopecia areata to be used once a day. 
Comparator Agent  Topical calcipotriol (0.005%) ointment along with narrowband (311 nm) ultraviolet B phototherapy  Both have synergistic therapeutic effect in treatment of alopecia areata. Topical Calcipotriol (0.005%) ointment to be used once a day and Narrowband ultraviolet B phototherapy exposure twice a week.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  - Patients of any age > 5 yrs, showing features of alopecia areata
- Patients with a diagnosis of patch type alopecia areata or alopecia totalis
- No evidence of regrowth present at baseline.
- Patient should be free from other modalities of treatment atleast for two weeks.
 
 
ExclusionCriteria 
Details  - Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis.
- Patients in whom the diagnosis of alopecia areata is in question.
- Patients with active medical conditions and other comorbid conditions like infection, eczematization that in the opinion of the investigator would alter the outcome of study evaluation.
- Patients with history or evidence of hematopoietic abnormality
- Patients with history or evidence of renal or hepatic impairment.
- Patients with history of immunosuppression or history of recurrent serious infections.
- History of photodermatitis or photosensitivity
- Patients taking oral corticosteroids or applying topical corticosteroids or treatment from outside.
- Patients with allergy to any component of calcipotriol preparation
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
HAIR GROWTH ASSESSMENT WILL BE DONE CLINICALLY BY PHOTOGRAPH WITH "SEVERITY OF ALOPECIA AREATA TOOL" SCORING AND BY TRICOSCAN INITIALLY, AFTER 4 WEEKS AND FINALLY AFTER 12 WEEKS.  4 weeks
12 weeks or complete resolution of alopecic lesion, whichever come first 
 
Secondary Outcome  
Outcome  TimePoints 
1. Continued hair density
2. Recurrence of lesion of alopecia.  		 up to 10 months after completion of treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/04/2014 
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="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   INTRODUCTION-. Alopecia areata is a hair disorder consisting of nonscarring hairloss because of autoimmune etiology. This affect individual of all age, races and gender and can involve hair of any anatomica part of body most commonly  scalp.
AIMS & OBJECTIVE- (1) To compare the two treatment modalities , topical calcipotrol (0.005%) Vs topical calcipotriol (0.005%) along                                               with NBUVB phototherapy   
                                     (2) To compare the followup improovment with these two treatments
                                     (3) Study of side effects in both treatments
METHODOLOGY- Sample size was 60, divided them into three groups (i.e. Group A, Group B and Group C) randomly. Group A with 25 subjects, received Topical Calcipotriol (0.005%) Ointment, once daily While Group B with 25 subjects, received Topical Calcipotriol (0.005%) Ointment once daily along with narrowband ultraviolet B (NBUVB) phototherapy twice weekly while Group C with 10 subjects, received placebo (Topical Vaseline) once daily. Outcomes in the form of improvement in “SEVERITY OF ALOPECIA TOOL” (SALT) scoring clinically and signs specific to AA in dermoscope with trichoscan were pursued at 6 week and 12 weeks.

 
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