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CTRI Number  CTRI/2026/02/103737 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
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 Prospective Comparative Study of Two Topical Treatment Regimens in Acne Vulgaris 
Scientific Title of Study   A prospective randomized open label study to compare the efficacy and tolerability of topical clindamycin 1% with and without topical benzoyl peroxide 2.5 percent in mild to moderate cases of acne. 
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 Simran Thory  
Designation  postgraduate  
Affiliation  kempegowda institute of medical sciences 
Address  kempegowda institute of medical sciences, pharmacology department(3 floor), Attimabe Road, Banashankari 2nd Stage, Near BDA Complex, Bengaluru, Karnataka

Bangalore
KARNATAKA
560070
India 
Phone  9680033837  
Fax    
Email  thorysimran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Girish 
Designation  Professor, Department of Pharmacology 
Affiliation  kempegowda institute of medical sciences 
Address  kempegowda institute of medical sciences, pharmacology department(3 floor), Attimabe Road, Banashankari 2nd Stage, Near BDA Complex, Bengaluru, Karnataka

Bangalore
KARNATAKA
560070
India 
Phone  9980911072  
Fax    
Email  girishkumaraswamy12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Girish 
Designation  Professor, Department of Pharmacology 
Affiliation  kempegowda institute of medical sciences 
Address  kempegowda institute of medical sciences, pharmacology department(3 floor), Attimabe Road, Banashankari 2nd Stage, Near BDA Complex, Bengaluru, Karnataka

Bangalore
KARNATAKA
560070
India 
Phone  9980911072  
Fax    
Email  girishkumaraswamy12@gmail.com  
 
Source of Monetary or Material Support  
kempegowda institute of medical sciences, pharmacology department(3 floor), Attimabe Road, Banashankari 2nd Stage, Near BDA Complex, Bengaluru, Karnataka India 560070 
 
Primary Sponsor  
Name  dr simran thory 
Address  kempegowda institute of medical sciences, pharmacology department(3 floor), Attimabe Road, Banashankari 2nd Stage, Near BDA Complex, Bengaluru, Karnataka India 560070 
Type of Sponsor  Other [kempegowda institute of medical sciences] 
 
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 Simran Thory   kims hospital  dermatology OPD(DR Soumya) department,2nd floor , B block , KIMS hospital K.R. Road, V.V. Puram (central),bangalore karnataka india
Bangalore
KARNATAKA 		 9680033837

thorysimran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kempegowda Institute of Medical Sciences Hospital & Research Centre, Bangalore  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 1% clindamycin gel  once daily at night 
Intervention  Topical combination of 1% clindamycin gel and 2.5% benzoyl peroxide gel  once daily at night  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Individuals of either gender aged 14 to 40 years. Clinically diagnosed with mild to moderate acne vulgaris. Investigator Global Assessment score of 2 or 3. Willing to provide written informed consent and adhere to study protocol and follow up visits. 
 
ExclusionCriteria 
Details  Use of any topical or systemic medication for the treatment of acne vulgaris within the preceding one month. Presence of severe inflammatory acne such as nodulocystic acne. Known hypersensitivity to any of the study medications including benzoyl peroxide or clindamycin. Pregnant or lactating women. History of use of corticosteroids, anti tubercular therapy or anti epileptic drugs. Underlying medical conditions including polycystic ovarian disease or hepatic impairment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Investigator Global Assessment score from baseline to Week 12.  Change in Investigator Global Assessment score from baseline, 4th week ,8th week and Week 12. 
 
Secondary Outcome  
Outcome  TimePoints 
incidence and severity of adverse effect during the study period   throughout study period  
 
Target Sample Size   Total Sample Size="358"
Sample Size from India="358" 
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)   25/02/2026 
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="6"
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   This is a prospective randomized open-label comparative study conducted at the Department of Dermatology, Kempegowda Institute of Medical Sciences, Bangalore. The study compares the efficacy and tolerability of topical clindamycin 1 percent gel alone versus topical clindamycin 1 percent gel combined with benzoyl peroxide 2.5 percent gel in treating mild to moderate acne vulgaris.
Participants will be randomly assigned to two treatment groups. Group C will receive topical clindamycin 1 percent gel twice daily. Group B will receive topical clindamycin 1 percent gel twice daily plus benzoyl peroxide 2.5 percent gel once daily at night. Treatment duration is 3 months with monthly clinical evaluations to assess acne severity using the Investigators Global Assessment scale, efficacy, and tolerability.
The study includes comprehensive informed consent forms in English and Kannada, participant information sheets, assent forms for minors, consent forms for medical photography, and detailed case record forms for systematic data collection. All participants will be monitored for common side effects including dryness, redness, burning sensation, itching, peeling, and irritation at the application site. 
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