| CTRI Number |
CTRI/2024/04/066416 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Observing dermoscopy changes in patients with non-sexually transmitted skin diseases of genitals |
|
Scientific Title of Study
|
Dermoscopy of all clinically diagnosed non-venereal genital dermatoses among patients attending tertiary care hospital Bhavnagar – An Observational Study |
| Trial Acronym |
DNVD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKSHAY PATIL |
| Designation |
1ST YEAR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Room No 115, Skin Department OPD,Sir T hospital,Jail Road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7738437657 |
| Fax |
|
| Email |
AKSPATIL786@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HITA MEHTA |
| Designation |
PROFESSOR AND HOD OF DEPARTMENT OF DERMATOLOGY AND LEPROSY |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Room No 115, Skin Department OPD,Sir T hospital,Jail Road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
HITAMEHTA88@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR AKSHAY PATIL |
| Designation |
1ST YEAR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Room No 115, Skin Department OPD,Sir T hospital,Jail Road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7738437657 |
| Fax |
|
| Email |
AKSPATIL786@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Sir T Hospital, Government Medical College, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
DR AKSHAY PATIL |
| Address |
Room No 115, Skin Department OPD,Sir T hospital,Jail Road, Bhavnagar |
| Type of Sponsor |
Other [SELF] |
|
|
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 AKSHAY PATIL |
SIR T HOSPITAL |
Room No 115, Skin Department OPD,Sir T hospital,Jail Road, Bhavnagar
Bhavnagar
GUJARAT |
7738437657
AKSPATIL786@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 65 years.
All the clinically diagnosed cases of genital cutaneous dermatoses. |
|
| ExclusionCriteria |
| Details |
Patients who have venereal genital lesions
Patient who are not willing to give written informed consent to participate in study.
Patient with prior topical or systemic treatment in past 3 month. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe Dermoscopic findings in patients of clinically diagnosed non-venereal genital dermatoses |
At the end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe new dermoscopic findings if any |
At the end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/05/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 come to
Dermatology OPD and clinical diagnosis of non-venereal
genital dermatosis will be made
•The patient will be assessed
for eligibility and will be included after photograph consent is given.
•The patient will be made to sit
comfortably and will be examined in ambient temperature.
•On the basis of history given by the
patient newest largest single lesion will be identified
and Dermoscopy will be performed with ‘DermLite DL5 Dermoscope.
•Data will be entered in excel file.
Analysis will be done using appropriate statistical software.
•Instrument used : “Dermlite DL5†This is a
handheld dermoscope and it will be connected to the mobile. The
images will be taken and the data will be saved on the computer.
•Method : For
examination, newest largest single lesion will be assessed on basis of
clinical history and dermoscopy and clinical photographs will be
taken, data will be compiled in master chart.
• After tabulation
of data, statistical analysis will be done. The categorical variable will be
analyzed by number, percentage, frequency.
|