FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091446 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [topical treatment ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Minocycline Gel with Clindamycin Gel in combination with benzoyl peroxide gel in patients of moderate to severe Acne Vulgaris. 
Scientific Title of Study   To compare the efficacy and safety of Topical Minocycline 4percent Gel versus Topical Clindamycin 1percent Gel in combination with benzoyl peroxide 2.5percent gel in patients of moderate to severe Acne Vulgaris. A Randomized active controlled 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 Yashdeep Singh Pathania 
Designation  Assistant Professor 
Affiliation  AIIMS Rajkot 
Address  Room 117, Department of Dermatology, AIIMS OPD Khandheri, Teh. Paddhari, Dist. Rajkot

Rajkot
GUJARAT
360110
India 
Phone  8894480089  
Fax    
Email  yashdeepsinghpathania@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yashdeep Singh Pathania 
Designation  Assistant Professor 
Affiliation  AIIMS Rajkot 
Address  Room 117, Department of Dermatology, AIIMS OPD,Khandheri, teh Paddhari, Dist Rajkot, Rajkot

Rajkot
GUJARAT
360110
India 
Phone  8894480089  
Fax    
Email  yashdeepsinghpathania@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yashdeep Singh Pathania 
Designation  Assistant Professor 
Affiliation  AIIMS Rajkot 
Address  Room 117, Department of Dermatology, AIIMS OPD,Khandheri, teh Paddhari, Dist Rajkot, Rajkot

Rajkot
GUJARAT
360110
India 
Phone  8894480089  
Fax    
Email  yashdeepsinghpathania@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rajkot 
Address  AIIMS,Khandheri, teh Paddhari, Dist Rajkot, Rajkot,Khanderi Rajkot 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 YashdeepSingh Pathania  All India Institute of Medical Sciences Rajkot  Room 117, Department of Dermatology, AIIMS OPD,Khandheri, teh Paddhari, Dist Rajkot, Rajkot
Rajkot
GUJARAT 
8894480089

yashdeepsinghpathania@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: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Topical Clindamycin 1% Gel  topical application of clindamycin 1% gel mixed with 1:1 ratio with benzoyl peroxide 2.5% gel will be applied over acne lesions once daily in patients of moderate to severe Acne Vulgaris 
Intervention  Topical Minocycline 4% Gel   topical application of minocycline 4% gel mixed with 1:1 ratio with benzoyl peroxide 2.5% gel will be applied over acne lesions once daily in patients of moderate to severe Acne Vulgaris 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Male or female individuals age 9 years and above.
Patients having acne vulgaris of moderate-to-severe facial acne, as defined by an Investigator’s Global Assessment (IGA) score of 3 or 4 and lesion counts of 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 noninflammatory lesions (open and closed comedone) Providing signed consent forms after understanding the written contents outlining the requirements of participating in the study.
 
 
ExclusionCriteria 
Details  Female subjects who are pregnant, lactating, or planning to become pregnant.
Use of oral retinoids or corticosteroids within 12 weeks
Use of topical retinoids, topical anti-inflammatory drugs and corticosteroids, oral antibiotics, or other systemic acne treatment within 4 weeks
• Patients with concomitant other skin diseases like psoriasis or urticaria.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A. Primary objective
1. The number of patients who achieved IGA-assessed treatment success in each group, i.e IGA score of 0 or 1(description of clear or almost clear) plus at least a 2-grade improvement from baseline.
2. To evaluate the change in absolute count of inflammatory and non-inflammatory lesions from baseline to the end of the study.
 
3 weekly till 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
B. Secondary objective
1. To compare the IGA score and absolute inflammatory and non-inflammatory lesions between the two groups A and B in each visit.
2. The safety will be assessed by treatment associated adverse events leading to discontinuation of the treatment.
3. The acne quality of life will be assessed at baseline and week 12 in each group
 
3 weekly till 12 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   02/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/08/2025 
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 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  

1.     Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit characterized by open or closed comedones (non-inflammatory), papules, pustules, nodules (inflammatory) on the face or trunk and may result in pain, erythema, hyperpigmentation or scars. It is one of the most common skin disorders worldwide, with an estimated global prevalence of 9.38%.1 As per Global burden of diseases study, acne affects approximately 85% of young adults.2 In India, acne is prevalent in 72.3% of adolescents and 27% of the adult age group.3Acne can be associated with poor quality of life leading to depression and anxiety. As per recent International guidelines, American academy of dermatology limits the use of systemic antibiotic use when possible to reduce the development of antibiotic resistance and other systemic side effects related to autoimmune reactions and gastrointestinal problems.4 The guidelines strongly suggest the use of topical antibiotics in combination with benzoyl peroxide to prevent development of resistance. Both topical minocycline and clindamycin are US FDA (Food and Drug Administration) approved for use in acne. However, there are very few studies in literature to compare the efficacy of topical antibiotics in moderate to severe acne vulgaris. Therefore, our study aim will be to compare the efficacy and safety of topical Minocycline 4% Gel with topical Clindamycin 1% Gel in combination with benzoyl peroxide 2.5% gel in patients of moderate to severe Acne Vulgaris.

2.     Hypothesis:  Topical minocycline 4% gel in combination with benzoyl peroxide 2.5% is non inferior to topical clindamycin 1 % gel with benzoyl peroxide 2.5% in patients of moderate to severe acne vulgaris.

3.     Research questions: Is topical minocycline 4% gel in combination with benzoyl peroxide 2.5% inot less efficacious than topical clindamycin 1 % gel with benzoyl peroxide 2.5% in patients of moderate to severe acne vulgaris?

 
Close