| CTRI Number |
CTRI/2024/11/076396 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Interventional study to compare the effectiveness of topical metformin 30% cream vs topical 0.025% tretinoin cream in the treatment of acanthosis nigricans-A randomized non inferiority assessor blinded study |
|
Scientific Title of Study
|
Comparison of effectiveness of topical metformin 30 percent cream vs topical 0.025 percent tretinoin cream in the treatment of acanthosis nigricans - A randomized non inferiority assessor blinded study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nibedita Dixit |
| Designation |
Assistant Professor |
| Affiliation |
ND SUM HOSPITAL |
| Address |
Ims and Sum Hospital,Dept of Dermatology, K8 kalinganagar
Ghatikia , khorda, Bhubaneswar,Odisha
Ims and sum hospital,Ghatikia , khorda, Bhubaneswar,Odisha
Khordha
ORISSA
751003
India |
| Phone |
08249855790 |
| Fax |
|
| Email |
buntinibs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
Professor and Hod |
| Affiliation |
ND SUM HOSPITAL |
| Address |
Ims and Sum Hospital,Dept of Dermatology,K8 kalinganagar
Ghatikia , khorda, Bhubaneswar,Odisha
Ims and sum Hospital, Dept of Dermatology,Ghatikia , khorda, Bhubaneswar,Odisha
Khordha
ORISSA
Bikash ranjan kar
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
Professor and Hod |
| Affiliation |
ND SUM HOSPITAL |
| Address |
Ims and Sum Hospital,Dept of Dermatology,K8 kalinganagar Ghatikia ,Bhubaneswar, Odisha
Ims and Sum Hospital, Dept of DermatologyGhatikia , khorda, Bhubaneswar,Odisha
Khordha
ORISSA
Bikash ranjan kar
India |
| Phone |
09937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Dermatology, Ims and sum Hopital, K8 kalinganagar, ghatikia, khorda, odisha. Pin-751003 |
| IMS AND SUM HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SOA university |
| Address |
Ims and sum Hospital,Dept of Dermatology,K8 Kalinganagar, Ghatikia,Khorda, Odisha. Pin-751003 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bikash ranjan kar |
IMS AND SUM HOSPITAL |
Dept of dermatology, k8 kalinganagar, ghatikia, pin-751003
Khordha
ORISSA |
09937428181
karbikash@gmail.com |
| Dr NIBEDITA DIXIT |
IMS AND SUM HOSPITAL |
K8 KALINGANAGAR GHATIKIA PIN-751
Khordha
ORISSA |
8249855790
buntinibs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS AND SUM HOSPITAL |
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 |
TOPICAL METFORMIN 30% for a duration of 8 weeks |
COMPARATIVE STUDY |
| Comparator Agent |
TOPICAL 0.025% TRETINOIN CREAM for a duration of 8 weeks |
COMPARATIVE STUDY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
All clinically diagnosed cases of acanthosis nigrican above 18 yrs of age |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and Lactation
2. Malignancy associated AN
3. Genetic or autoimmune AN
4. Syndromic AN
5. History of allergy to metformin
6. Type II diabetes mellitus, coagulopathy, liver disease), immunocompromised hosts, infection
7. Patients not on any topical or systemic therapy for AN in last 1 month
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| on photographic assessment and quantitative assessment using ANSC score. |
on photographic assessment and quantitative assessment to be done at 0,4,8,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety profile |
It may be discontinued if patient denies because of severe pain , edema, erythema, blisters at 0,4,8,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
15/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
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 meeting the clinical criteria will be divided into two groups. One group will receive metformin 30% cream and the other group will receive 0.025% tretinoin cream. Patient will be analysed every month for a duration of 8weeks. Metformin has a melanopenic effects because itinhibits the production of MITF which in turn inhibits the transcription of a number of melanogenic proteins. |