| CTRI Number |
CTRI/2023/01/048858 [Registered on: 10/01/2023] Trial Registered Prospectively |
| Last Modified On: |
29/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical and Dermoscopic evaluation of effectiveness of Metformin vs Pioglitazone in Acanthosis Nigricans. |
|
Scientific Title of Study
|
Clinical and Dermoscopic evaluation to study the effectiveness of Metformin vs Pioglitazone in Acanthosis Nigricans - A Randomised Control Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jinisha Anand Jain |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Dermatology, Venereology, and Leprosy.
Jawaharlal Nehru Medical College, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
08788120627 |
| Fax |
|
| Email |
jinishaarts1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Doshi |
| Designation |
Head of Department and Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Dermatology, Venereology, and Leprosy.
Jawaharlal Nehru Medical College, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9422306523 |
| Fax |
|
| Email |
bhavs1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jinisha Anand Jain |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Dermatology, Venereology, and Leprosy.
Jawaharlal Nehru Medical College, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8788120627 |
| Fax |
|
| Email |
jinishaarts1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research - KLE University Grant |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research - KLE University Grant |
| 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 Jinisha Anand Jain |
Dermatology and Endocrine OPD KLES Prabhakar Kore Hospital, |
Dermatology OPD no. 23, First Floor - Krishna,
Endocrine OPD no - 1, Ground Floor - Cauvery KLES Prabhakar Kore Hospital, Nehru Nagar, Belagavi 590010, Karnataka
Belgaum
KARNATAKA |
8788120627
jinishaarts1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC 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
|
| Type |
Name |
Details |
| Intervention |
Metformin |
500 mg BD for 12 weeks |
| Comparator Agent |
Pioglitazone |
7.5 mg BD for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
•Adult patients (≥18 years) with acanthosis nigricans attending the outpatient department of dermatology in KLE Prabhakar Kore Hospital
•Patients from whom written informed consent is obtained
|
|
| ExclusionCriteria |
| Details |
•Patients already taking any oral hypoglycemic drug.
•Patient diagnosed as Type 1 Diabetes Mellitus
•Patient diagnosed as Drug induced AN
•Patients diagnosed as AN due to known malignancy
•Pregnant and lactating mothers
•Known allergic reaction to either Metformin or Pioglitazone
•Contraindicated for taking metformin or Pioglitazone
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the reduction of neck lesions of Acanthosis Nigricans calculated using Burkes Grading |
At the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermoscopic evaluation of reduction of severity of neck lesions in Acanthosis Nigricans |
At the end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/01/2023 |
| 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
|
nil |
|
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 randomized open label trial comparing the clinical and dermoscopic effectiveness of Metformin 500mg BD with Pioglitazone 7.5 mg BD in Acanthosis Nigricans patients in a tertiary care hospital in Karnataka. The primary outcomes being clinical effectiveness calculated by Burkes Grading and secondary outcome by Dermocopic evaluation . |