| CTRI Number |
CTRI/2024/07/070444 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effects of the drug metformin as a cream for patients with melasma |
|
Scientific Title of Study
|
An interventional study to evaluate the efficacy and safety of topical metformin in the treatment of melasma at a tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu Sarah Philip |
| Designation |
Fellow in Aesthetic Dermatology |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Dermatology, Bangalore Medical College and Research Institute, K.R Market, Bengalurur
Bangalore
KARNATAKA
560002
India |
| Phone |
8921538863 |
| Fax |
|
| Email |
anu.philips@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita A Hongal |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Dermatology, Bangalore Medical College and Research Institute, K.R Market, Bengaluru
KARNATAKA
560002
India |
| Phone |
8921538863 |
| Fax |
|
| Email |
amritahongalleo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anu Sarah Philip |
| Designation |
Fellow in Aesthetic Dermatology |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Dermatology, Bangalore Medical College and Research Institute, K.R Market, Bengaluru
KARNATAKA
560002
India |
| Phone |
8921538863 |
| Fax |
|
| Email |
anu.philips@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, K.R Market, Bengaluru, 560002 |
|
|
Primary Sponsor
|
| Name |
Anu Sarah Philip |
| Address |
Department of Dermatology, Bangalore Medical College and Research Institute, K.R Market, Bengaluru, 560002 |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
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 Anu Sarah Philip |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Room No 53, B Block, Department of Dermatology
Bangalore
KARNATAKA |
8921538863
anu.philips@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin cream |
Once daily application on the face at night for 12 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ADULT MALES OR FEMALES WITH A CLINICAL DIAGNOSIS OF MELASMA |
|
| ExclusionCriteria |
| Details |
Age less than 18 years or more than 80 years.
Pregnant.
Lactating.
Patients with a history of photosensitivity disorders.
Patients on medications known to cause hyperpigmentation or photosensitivity.
Patients on immunosuppressants .
Patients with facial pigmentation caused by conditions other than melasma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with reduction in modified melasma area and severity index |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with reduction in dermoscopy score |
12 weeks |
| Percentage of patients with increase in patient satisfaction scale. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anu.philips@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an interventional study to evaluate the efficacy and safety of topical metformin cream once daily in treating 30 patients with melasma for 12 weeks that will be conducted in a single tertiary care centre in India. The primary outcome measure will be percentage of patients with reduction in modified melasma area and severity index score at 12 weeks . The secondary outcomes will be the percentage of patients with reduction in dermoscopy score and increase in patient satisfaction score at 12 weeks |