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CTRI Number  CTRI/2024/11/076414 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Nailfold capillaroscopy in psoriasis patients before and after treatment 
Scientific Title of Study   Evaluation of the nailfold capillaroscopic findings in the patients of psoriasis at baseline and psoriasis area severity index 75 after methotrexate therapy: A prospective observational 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  Dr Seema Punia 
Designation  Post Graduate Resident 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Department of Dermatology AIIMS Bathinda Mandi Dabwali road Bathinda Punjab India

Bathinda
PUNJAB
151001
India 
Phone  8955665220  
Fax    
Email  seemapunia4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavita Poonia 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Department of Dermatology AIIMS Bathinda Mandi Dabwali road Bathinda Punjab India

Bathinda
PUNJAB
151001
India 
Phone  9646091743  
Fax    
Email  kavitapoonia777@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Bansal  
Designation  Assistant professor 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Department of Dermatology AIIMS Bathinda Mandi Dabwali road Bathinda Punjab India

Bathinda
PUNJAB
151001
India 
Phone  8287020404  
Fax    
Email  drshivani.derm@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology,All India Institute of Medical Sciences , Bathinda 
Indian Association of Dermatologists, Venerologists and Leprologists 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bathnida 
Address  All India Institute of Medical Sciences, Jodhpur Ramana, Dabawali road,Bathinda, Punjab,pin-151001 
Type of Sponsor  Research institution and hospital 
 
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 Seema Punia  All India Institute of Medical Sciences, Bathinda  Room no. 2111,1st Floor B block, Outpatient Department of Dermatology
Bathinda
PUNJAB 		 8955665220

seemapunia4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committtee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having moderate to severe plaque psoriasis with psoriais area and severity index more than 10
Patients not taking any systemic treatment since last 1month
Patients who are willing to sign the written consent form before participating in the study  
 
ExclusionCriteria 
Details  Patients having connective tissue disorders
Patients with diabetes mellitus or peripheral vascular disease or coronary disease or cerebrovascular disease
Patients with active visible trauma or cosmetic operations or those with a history of professional finger trauma
Pregnant and lactating females
Patients with contraindications to methotrexate therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of the nailfold capillaroscopic findings in the patients of psoriasis at baseline and psoriasis area severity index 75 after methotrexate therapy   At baseline and at PASI75 OR 16th week whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate nailfold capillaroscopic findings with the biochemical marker of endothelial function   At baseline only 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/12/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Patient will be included after taking informed consent.Clinical Examination will be done and determine the extent of Psoriasis Vulgaris, which will be assessed using the Psoriasis Area and Severity Index (PASI) Score.
Nailfold examination : will be done on 4th and 5th fingers of both hands using video dermatoscope and serial photographs will be taken. The parameters including mean capillary loop density, morphology of capillaries, avascular areas and microhaemmorhages will be assessed.
Biochemical Investigation – Endothelial marker {Asymmetric Dimethylarginine (ADMA)} levels will be measured using commercially available ELISA kits.

Methotrexate therapy will be given in dose of 0.4mg/kg/week and maximum upto   25mg/week. Folic acid (5mg/day biweekly except on the day of methotrexate), emollients and antihistaminics will be used as concomitant therapy.

Follow up assessment:Clinical evaluation well be done at 2 weekly for 1st 4weeks and then 4weekly upto 16th weeks.Nailfold capillaroscopic examination will be done when the patient will achieve more than 75% reduction in PASI from baseline or at 16weeks, whichever will be earlier.


 

 
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