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CTRI Number  CTRI/2024/09/073949 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized, Open-Label, Prospective Clinical Trial comparing Doxycycline and Metformin for Acne Vulgaris Patients 
Scientific Title of Study   A Randomized, Open Label, Prospective study to compare Efficacy of Metformin vs. Doxycycline in patients with Acne Vulgaris 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KAPIL KAKTAN 
Designation  PG JR 1 
Affiliation  UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES 
Address  2nd Floor Academic Block, Pharmacology Department, Uttar Pradesh University of Medical Sciences, Saifai , Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  7717635209  
Fax    
Email  kaktankapil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Alok Dixit 
Designation  Professor and Head of Department 
Affiliation  UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES 
Address  2nd Floor, Academic Block, Pharmacology Department, Uttar Pradesh University of Medical Sciences, Saifai , Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9639523852  
Fax    
Email  alkdxt@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  KAPIL KAKTAN 
Designation  PG JR 1 
Affiliation  UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES 
Address  2nd Floor, Academic Block, Pharmacology Department, Uttar Pradesh University of Medical Sciences, Saifai , Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  7717635209  
Fax    
Email  kaktankapil@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical Sciences, Saifai , 206130, Etawah, India 
 
Primary Sponsor  
Name  Uttar Pradesh University of Medical Sciences Saifai 
Address  SAIFAI, ETAWAH, 206130, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 KAPIL KAKTAN  Uttar Pradesh University of Medical Sciences,, SAIFAI  Room no. 17, Dermatology OPD, Uttar Pradesh University of Medical Sciences, SAIFAI, ETAWAH, 206130
Etawah
UTTAR PRADESH 		 7717635209

kaktankapil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Benzoyl Peroxide   gel benzoyl peroxide 5%, local application once daily for 3 months.  
Intervention  METFORMIN, DOXYCYCLIN   METFORMIN oral tablet metformin 500 mg twice daily for 3 months. DOXYCYCLIN oral tablet 100 mg twice daily for 3 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Moderate-to-severe acne
2. Who had not received systemic or topical treatment in the past 4 weeks ( systemic antibiotics, retinoids, corticosteroids or immunosuppressive agents) 
 
ExclusionCriteria 
Details  1. Patients with systemic diseases, including diabetes mellitus, kidney/liver dysfunction,
2. Pregnant and lactating women,
3. Those who are reluctant to come for regular follow up,
4. Those who reported a positive history of allergy to the study drugs,
5. Those who used drugs that interact with metformin or doxycycline,
6. Those who used contraceptive medications containing estrogen or progesterone,
7. Addiction to smoking and alcohol,
8. History of migraine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The percentage change in inflammatory and total lesion counts at baseline , 4 weeks, 8 weeks, and 12 weeks.  at baseline, 4 weeks, 8 weeks, and 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in GAGS grading, improvement in CADI score at week 12  at baseline, 12 weeks. 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   21/09/2024 
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="1"
Months="0"
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kaktankapil@gmail.com].

  6. For how long will this data be available start date provided 22-06-2024 and end date provided 22-06-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background: Acne, one of the most prevalent chronic inflammatory skin conditions nowadays, is treated with benzoyl peroxide (alone or in conjunction with topical antibiotics and oral antibiotics, mainly doxycycline). With puberty, sebum excretion starts to rise with the maximum level of growth hormone and insulin, like Growth Factor-1. IGF-1 plays an important role in the pathogenesis of acne. Oral metformin decreases IGF-1 levels and improves acne.

 

Methods: To evaluate the efficacy and safety of metformin vs. doxycycline, a prospective, randomized, open-label study is to be conducted on patients with acne vulgaris. The patients will be randomly assigned in a 1:1 ratio, consisting of 80 patients in each group. Group 1 will receive 500 mg of metformin tablets twice daily with a 5% benzoyl peroxide ointment once daily, and Group 2 will receive 100 mg of doxycycline tablets twice daily with a 5% benzoyl peroxide ointment once daily for 12 weeks. Patients will be assessed based on the Global Acne Grading System, Total Lesion Count, and Cardiff Acne Disability Index.

 

Novelty: To compare efficacy and safety of metformin vs. doxycycline in patients receiving prescription medication for acne vulgaris in dermatology (OPD, UPUMS, Saifai).

 

Expected Outcome: The change in inflammatory total lesion count from baseline at week 12 will be the primary effectiveness outcome. Improvement in GAGS grading, improvement in CADI scores at week 12, and improvement in two grades from baseline are the other secondary efficacy goals.

 
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