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CTRI Number  CTRI/2017/08/009366 [Registered on: 14/08/2017] Trial Registered Retrospectively
Last Modified On: 12/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A study of clinical and dermoscopic nail changes in patients with psoriasis 
Scientific Title of Study   A study of clinical and dermoscopic nail changes in patients with psoriasis and its correlation with the NAPSI score 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Suvarna 
Designation  Postgraduate Resident 
Affiliation  Father Muller Medical College 
Address  Department of Dermatology, Father Muller Medical College Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9968115738  
Fax    
Email  chuvvi89@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sukumar D 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Department of Dermatology Father Muller Medical College, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone    
Fax    
Email  drsukumar_d@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  S Suvarna 
Designation  Postgraduate Resident 
Affiliation  Father Muller Medical College, 
Address  Department of Dermatology Father Muller Medical College, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8546896252  
Fax    
Email  chuvvi89@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College, Kankanady, Mangalore, Karnataka 575002 
 
Primary Sponsor  
Name  S SUVARNA 
Address  Department of Dermatology, Kankanady, Mangalore, Karnataka-575002 
Type of Sponsor  Other [Self funding] 
 
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 
S SUVARNA  Father Muller Medical College,  Department of Dermatology Father Muller Medical College, Kankanady, mangalore
Dakshina Kannada
KARNATAKA 
8546896252

chuvvi89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PSORIASIS 
Patients  PSORIASIS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Persons willing to participate in the study.
2. All the patients with clinical diagnosis of psoriasis with nail changes.
3. All age and sex matched healthy volunteers.
 
 
ExclusionCriteria 
Details  1. Persons who are not willing for the study.
2. Persons with onychomycosis or other nail disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NAPSI Score  Two years 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2015 
Date of Study Completion (India) 31/03/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

  The following study is a case control study to compare the clinical and dermoscopic nail changes in 45 patients with psoriasis with 45 age and sex matched healthy individuals; and to study their correlation with the NAPSI score.

Psoriasis is a chronic inflammatory disorder of the skin, of multifactorial pathogenesis characterized by altered epidermal growth and differentiation. It affects 1-3% of the world’s population. Nails are commonly affected in upto 50 percent of patients with psoriasis and in upto 80 percent of patients with psoriatic arthritis. Several distinct changes such as pitting, onycholysis, salmon patches, hemorrhages and subungual hyperkeratosis are seen in the nail plate and indicate severe cutaneous psoriasis and are also closely associated with joint inflammation. However, by the time these changes are detected grossly, the nail would have been severely damaged, affecting the day to day life of the individual.

Dermoscopy is a noninvasive technique which is commonly used to obtain a rapid and magnified in vivo observation of the nail with better visualization of abnormalities in the hyponychium and proximal nail fold. It may help in the diagnosis of nail psoriasis in inconclusive cases and improve the follow-up of the patient with respect to his/her response to treatment.

NAPSI and modified NAPSI scoring systems are commonly used to assess the extent and severity of psoriatic nail changes. They also show a significant correlation with psoriatic arthritis.Very few studies have been done to detect nail changes and calculate NAPSI scores using dermoscopy.

  

  

 
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