| CTRI Number |
CTRI/2022/05/042703 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
16/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the assosciation of severity of acanthosis nigricans with the metabolic syndrome |
|
Scientific Title of Study
|
Study of metabolic syndrome in patients with acanthosis nigricans. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chinmay Kumar Mandal |
| Designation |
Junior Resident |
| Affiliation |
Pandit BD Sharma, PGIMS, Rohtak |
| Address |
Dermatology OPD, Department of Dermatology, Venerology and Leprosy PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8908473073 |
| Fax |
|
| Email |
mandal.chinmay4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Aggarwal |
| Designation |
Professor, Department of Dermatology |
| Affiliation |
Pandit BD Sharma, PGIMS, Rohtak |
| Address |
Dermatology OPD, Department of Dermatology, Venerology and Leprosy PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416357200 |
| Fax |
|
| Email |
drkamalaggarwal@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Chinmay Kumar Mandal |
| Designation |
Junior Resident |
| Affiliation |
Pandit BD Sharma, PGIMS, Rohtak |
| Address |
Dermatology OPD, Department of Dermatology, Venerology and Leprosy PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8908473073 |
| Fax |
|
| Email |
mandal.chinmay4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt BD Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pandit BD Sharma PGIMS Rohtak |
| Address |
Pandit BD Sharma, PGIMS, Rohtak |
| 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 |
| Chinmay Kumar Mandal |
Pt BD Sharma PGIMS, Rohtak |
Dermatology OPD, Department of Dermatology, Venerology ans Leprosy, PGIMS Rohtak
Rohtak
HARYANA |
8908473073
mandal.chinmay4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt BD Sharma, PGIMS, Rohtak |
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 |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Acanthosis Nigricans aged ≥18 years and comprising of both sexes. |
|
| ExclusionCriteria |
| Details |
1) Patients with a history of intake of drugs which may lead to development of AN such
as nicotinic acid, oral contraceptives, systemic steroids, diethylstilbestrol, antiretroviral
drugs, and application of topical fusidic acid.
2) Patients with pregnancy and in the postpartum period up to 6 months.
3) Patients with family history of diabetes, hypertension and familial dyslipidemia,
4) Patients with history of endocrine diseases like Cushing syndrome, acromegaly,
pheochromocytoma, hyperthyroidism, glucagonoma.
5) Participants with history of smoking and alcohol use.
6) Patients with skin diseases that are known to be associated with metabolic syndrome
such as psoriasis, lichen planus, androgenic alopecia, acne, systemic lupus
erythematous, vitilgo etc.
7) Patients with family history of acanthosis nigricans.
8) Patients on drugs known to cause hypertension, hyperglycemia and hyperlipidemia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study clinical features of patients with acanthosis nigricans |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of metabolic syndrome with extent and severity of Acanthosis Nigricans |
1 year |
|
|
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)
|
26/05/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After taking approval from ethics committee, study will be initiated, patients fulfilling the inclusion criteria will be taken into the study. This will be an observational, non-interventional, cross sectional study to determine the association of metabolic syndrome with Acanthosis Nigricans and to determine the association with the severity of Acanthosis nigricans in patients aged 18-70 years that will be conducted in the skin OPD at PGIMS, Rohtak.
|