| CTRI Number |
CTRI/2024/11/076845 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Interventional study comparing the effectiveness of topical metformin 30 % cream plus hydroquinone 4 % cream vs topical hydroquinone 4% cream alone in melasma -a randomised non inferiority open label study. |
|
Scientific Title of Study
|
Comparison of effectiveness of topical metformin 30% plus 4%hydroquinone cream vs topical hydroquinone 4% cream alone in melasma -A randomised non inferiority open lable 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 |
IMS AND SUM HOSPITAL |
| Address |
IMS AND SUM HOSPITAL, Dept of dermatology K8 kalinganagar
Ghatikia , khorda, bhubaneswar,odisha
Ims and sum hospital, dept of dermatology, k8 kalinganagar, ghatikia, khorda
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 |
IMS AND SUM HOSPITAL |
| Address |
Ims and sum hospital, Dept of dermatology, K8 kalinganagar ghatikia
Ims and sum hospital, Dept of dermatology, K8 kalinganagar, ghatikia, khorda
ORISSA
751003
India |
| Phone |
08249855790 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikash ranjan Kar |
| Designation |
Professor and Hod |
| Affiliation |
IMS AND 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
751003
India |
| Phone |
08249855790 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS AND SUM HOSPITAL |
| IMS AND SUM HOSPITAL, Dept of dermatology, k8 kalinganagar ghatikia |
|
|
Primary Sponsor
|
| Name |
SOA university |
| Address |
K8 KALINGANAGAR GHATIKIA
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 |
| Bikash ranjan kar |
IMS AND SUM HOSPITAL |
Dept of dermatology, k8 kalinganagar, ghatikia, pin-751003
Khordha
ORISSA |
9937428181
karbikash@gmail.com |
| NIBEDITA DIXIT |
IMS AND SUM HOSPITAL |
K8 kalinganagar
Ghatikia , khorda, bhubaneswar,odisha
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: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2. topical hydroquinone 4 % cream at night for a duration of 8 weeks |
2. Second group shall be treated with topical hydroquinone 4 % cream at night for 8 weeks |
| Intervention |
topical metformin 30% plus 4% hydroquinone cream for a duration of 8 weeks |
1. One group shall be treated with topical metformin 30% plus 4% hydroquinone creamfor 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
.All clinically diagnosed cases of melasma cases from 18 to 60 years of age
2. Who are not currently on any topical or systemic melasma treatments for one month and who did not receive any cosmetic procedures such as laser ablation, dermabrasion or peels for the last 3 months.
|
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
2. Active acne vulgaris and Rosacea
3. Females on Oral Contraceptive pills
4. History of allergy to metformin
5. Allergic to propylene glycol
6. H/O liver or Kidney dysfunction
|
|
|
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 mMASI score. |
Assessment to be done on every monthly for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SAFETY PROFILE |
Any patients developing side effects like pruritus, allergic reactions, erythema |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/11/2024 |
| 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 divided into two group. One group to receive metformin 30 % cream plus hydroquinone cream and the other group to receive only hydroquinone cream .Low cost of metformin tablets and ease of preparation of desired formulations makes its a cost effective option for the management of melasma. |