| CTRI Number |
CTRI/2018/05/014206 [Registered on: 29/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
31/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dermoscopy of scalp and hair disorders |
|
Scientific Title of Study
|
Clinical and Dermoscopic findings of scalp and hair disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vrutika Shah |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Department of Dermato-Venereo-Leprology,
Government Medical College, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9870894102 |
| Fax |
|
| Email |
vrutikashah25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh P Singh |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Department of Dermato-Venereo-Leprology,
Government Medical College, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9373107692 |
| Fax |
|
| Email |
rpsingh13m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh P Singh |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Department of Dermato-Venereo-Leprology,
Government Medical College, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9373107692 |
| Fax |
|
| Email |
rpsingh13m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermato-Venereo-Leprology,
Government Medical College, Nagpur |
|
|
Primary Sponsor
|
| Name |
Government Medical College |
| Address |
Department of Dermato-Venereo-Leprology,
Government Medical College, Nagpur |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Vrutika Shah |
Department of Dermato-Venereo-Leprology |
Government Medical College and hospital, Near Medical square, Nagpur
Nagpur
MAHARASHTRA |
9870894102
vrutikashah25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, Government Medical college, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Scalp and hair disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All male and female patients of any age with scalp and hair disorders attending the department of Dermatology, venereology and leprology |
|
| ExclusionCriteria |
| Details |
Hair loss occuring due to external injury
Patients with active secondary bacterial infection in the alopecia patch |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the clinical and dermoscopic findings of scalp and hair disorders |
day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the utility of dermoscopy in the diagnosis of scalp and hair disorders |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
02/12/2016 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dermoscopy is a non-invasive examination technique of evaluation of the colors and microstructures of the epidermis, dermoepidermal junction and papillary dermis which all are not visible to the naked eye; hence enhancing the diagnostic accuracy. The standard methods used to diagnose hair loss disorders (e.g. simple clinical inspection, pull test and biopsy) vary in sensitivity, reproductibility and invasiveness. Dermoscopy is a new and valuable tool in this era. Subtle features (e.g. hair shafts, hair follicle openings, the perifollicular epidermis and cutaneous mircovessels) not seen with the naked eye are visibly enhanced. Scalp dermoscopy not only facilitates diagnosis of hair disorders but it can also give clues about disease stage and progression.
The number of studies carried out on dermoscopy of scalp and hair disorders in India is limited. Hence, the current study is undertaken to evaluate the use of dermoscopy in diagnpsing cictricial alopecia, non-cictricial alopecia, hair shaft disorders and inflammatory scalp diseases. |