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CTRI Number  CTRI/2025/04/084241 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the Effectiveness, Safety, and Cost of Minocycline Gel vs. Adapalene plus Benzoyl Peroxide Gel for Mild to Moderate Facial Acne, A randomized study 
Scientific Title of Study   Comparative study of efficacy, safety and cost effectiveness of Minocycline 4 percent gel and Adapalene 0.1 percent plus Benzoyl peroxide 2.5 percent combination gel in mild to moderate facial Acne vulgaris. A prospective, randomized, open labelled parallel 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 Ganesh Dakhale 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Nagpur 
Address  Department of Pharmacology All India Institute of Medical Sciences Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  9850539353  
Fax    
Email  gndakhle@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nishanth P 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Nagpur 
Address  Department of Pharmacology All India Institute of Medical Sciences Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  7826872358  
Fax    
Email  nishanthgdrive@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishanth P 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Nagpur 
Address  Department of Pharmacology All India Institute of Medical Sciences Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  7826872358  
Fax    
Email  nishanthgdrive@gmail.com  
 
Source of Monetary or Material Support  
Dr Nishanth Parameswaran,Junior Resident, Department of Pharmacology, AIIMS Nagpur, MIHAN, Nagpur, Maharashtra, India. Pin code- 441108 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Nagpur 
Address  All India Institute of Medical Sciences Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra Pin 441108 
Type of Sponsor  Other [Institution of National Importance] 
 
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 Ganesh Dakhale  All India Institute of Medical Sciences Nagpur  Department of Pharmacology, Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra 441108
Nagpur
MAHARASHTRA 		 9850539353

gndakhle@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Nagpur  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  Topical Adapalene 0.1% - Benzoyl peroxide 2.5% gel  Participants will be advised to apply one fingertip unit (0.5 grams) of Deriva-Bpo Gel from Glenmark Pharmaceuticals Ltd, once daily at night for a duration of 8 weeks 
Intervention  Topical Minocycline 4% gel  Participants will be advised to apply one fingertip unit (0.5 grams) of Minym Gel from Glenmark Pharmaceuticals Ltd, once daily at night for a duration of 8 weeks 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients of either gender aged between 12 and 40 years, suffering from mild to moderate facial acne vulgaris, having a GAGS score less than or equal to 30, willing to give written informed consent who had not taken topical antiacne medications in last 14 days and, systemic medications in last 30 days will be included in this study
 
 
ExclusionCriteria 
Details  Patients already on topical anti-acne medication for 14 days, use of systemic therapy within last 30 days before inclusion into the study, patients with a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis, or eczema, patients who were on oral contraceptive pills in the last 12 weeks, patients unwilling to give written informed consent, Individuals with secondary acne, such as occupational acne or drug induced acne, patients who have known hypersensitivity to adapalene, minocycline, benzoyl peroxide or any ingredient of the study drug, Pregnant or lactating women and the patients who the investigator deemed to be unsuitable for any reason will be excluded from the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The mean reduction in GAGS score from baseline to week 8 in each treatment regimen group will be the primary outcome of the study  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Number of adverse events in each treatment regimen group as reported by patients or observed by investigator over the duration of 8 weeks of treatment will be secondary outcome of this study  0 to 8 weeks 
The Cost effectiveness ratio of each treatment regimen by calculating the Average and Incremental Cost Effectiveness Ratio by the end of 8 weeks will be a secondary outcome of this study  8 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   21/04/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Acne vulgaris is a chronic inflammatory skin condition with significant psychosocial impact, requiring effective and well-tolerated treatment especially in a developing country like India. This study would provide valuable data of the first head to head comparison of the efficacy, safety, and cost-effectiveness of minocycline 4% gel and adapalene 0.1%–benzoyl peroxide 2.5% gel in mild to moderate cases. Conducted at AIIMS Nagpur with 80 patients in a randomized, open-label design, it assesses outcomes over eight weeks. The study findings will aid clinical decision-making, optimizing treatment protocols and potentially reducing reliance on systemic therapies. 
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