| CTRI Number |
CTRI/2025/01/078918 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to evaluate between topical metformin 30 percent vs topical benzoyl peroxide 2.5 percent in acne vulgaris |
|
Scientific Title of Study
|
Comparison of effectiveness of topical metformin 30 percent gel vs topical benzoyl peroxide 2.5 percent gel alone in acne vulgaris a randomized non inferiority open label 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 |
Dr Bikash Ranjan Kar |
| Designation |
Professor & HOD |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of dermatology, IMS & SUM Hospital, K8 Kalinganagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikash Ranjan Kar |
| Designation |
Professor & HOD |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of dermatology, IMS & SUM Hospital, K8 Kalinganagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bikash Ranjan Kar |
| Designation |
Professor & HOD |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of dermatology, IMS & SUM Hospital, K8 Kalinganagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOSPITAL |
| Address |
IMS & SUM Hospital
K8 Kalinganagar
Bhubaneswar
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Bikash Ranjan Kar |
IMS AND SUM HOSPITAL |
Department of dermatology
Khordha
ORISSA |
09937428181
karbikash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical benzoyl peroxide 2.5 percent |
It will be applied topically once daily for 8 weeks |
| Intervention |
Topical metformin 30 percent |
It will be applied topically once daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All clinically diagnosed cases of acne vulgaris cases more than 18 years of age consenting for the study |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
Patients who received any systemic/topical treatment within 1 month prior to enrollment.
Patients with acne Tarda
Nodulocystic acne
Females on Oral Contraceptive pills
H/O liver or Kidney dysfunction, diabetes
Those with features of hyperandrogenism like hirsutism, irregular menses, FPHL.
K/C/O PCOD
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the decrease in lesional count
|
At baseline, 4 weeks, 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life |
At baseline, 4 weeks, 8 weeks
|
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The patients meeting all the inclusion criteria and not meeting any exclusion criteria shall be considered to participate in the study A detailed history including the duration of disease, associated medical conditions, treatment history and family history is to be taken The patients are randomized according to random number generator and allocated to two interventional group Assessor shall be blinded Two medications shall be given One group will be given topical metformin 30% gel once daily application at night for 8 weeks The other group will be given topical benzoyl peroxide 2.5% gel once daily application at night in acne for 8 weeks Acne lesions were counted and documented according to type (comedones, papules, pustules, nodules) at the first visit and every follow up Follow up is done at baseline, 4th, 8th, 12th and 16th week Clinical photographic assessment and quantitative assessment by counting the number of facial inflammatory lesions will be done at every 4 weeks till 16 weeks Global assessment of improvement should be done by the investigator at each visit, according to the following criteria - excellent for greater thant 75% improvement, good for about 50% improvement, fair for about 25% improvement and poor for little or no improvement Any patient developing side effects shall be pulled out of intervention |