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
|
|
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
|
|
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. | |