| CTRI Number |
CTRI/2023/06/054301 [Registered on: 22/06/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of Clinical and Dermoscopic Findings in Acanthosis Nigricans |
|
Scientific Title of Study
|
Study of Association of Clinical and Dermoscopic Findings with Nail Fold Capillaroscopy changes in Acanthosis Nigricans: A one year cross sectional study at a tertiary care hospital |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi P Shete |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
OPD No 23 Dermatology, Room number 2, KLEH Dr Prabhakar Kore Hospital, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9371011096 |
| Fax |
|
| Email |
aditishete52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavana R Doshi |
| Designation |
Head of Department, Department of Dermatology, JNMC Belagavi |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
OPD No 23, KLEH Dr Prabhakar Kore Hospital, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9422306523 |
| Fax |
|
| Email |
bhavs1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi P Shete |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
OPD No 23 Dermatology,Room number 2, KLEH Dr Prabhakar Kore Hospital, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9371011096 |
| Fax |
|
| Email |
aditishete52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Nehru Nagar Belagavi, Karnataka, 590010 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal nehru medical college, belgaum |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010 |
| Type of Sponsor |
Private 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 Aditi P Shete |
KLEH, Dr Prabhakar Kore Hospital |
OPD 23,Dermatology, Room No. 2 KLEH, Dr Prabhakar Kore Hospital, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA |
9371011096
aditishete52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L83||Acanthosis nigricans, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients will include all clinically diagnosed cases of acanthosis nigricans between the age group 5 years to 70 years |
|
| ExclusionCriteria |
| Details |
1. Patients not willing/ not consenting for investigations
2. Patients having concomitant infection or other skin condition affecting the area of acanthosis nigricans
3. Mehndi Application over proximal nail folds
4. Infection or inflammatory conditions involving the nail fold unit
5. Patients having concomitant rheumatological conditions like scleroderma, Systemic Lupus Erythematosus, Dermatomyositis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for association of Nail Fold Capillaroscopy changes & its significance in Acanthosis Nigricans |
As it is a cross sectional study observations will be made only the first time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/07/2023 |
| 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="0"
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
|
This study is a observational cross sectional study, studying the association of clinical and dermoscopic findings with nailfold capillaroscopy changes in acanthosis nigricans that will be conducted in KLEH, Dr Prabhakar Kore Hospital, Belagavi.T he primary outcome is to look for association of Nail Fold capillaroscopy changes and its significance in acanthosis nigricans. |