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CTRI Number  CTRI/2026/03/105999 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 17/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to see whether adding probiotics to regular skin treatment improves Acne in young adults 
Scientific Title of Study   To Compare the Efficacy and Safety of Probiotics as an Add on Therapy Vs Topical Therapy alone in patients of Acne Vulgaris A Randomized Controlled 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  Rajat Gupta 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 
Address  Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  7454072462  
Fax    
Email  grajat339@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Farhan Ahmad Khan 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 
Address  Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  9759468300  
Fax    
Email  dr.farhan.k@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajat Gupta 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 
Address  Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  7454072462  
Fax    
Email  grajat339@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College Aligarh Muslim University 
 
Primary Sponsor  
Name  Rajat Gupta 
Address  Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 
Type of Sponsor  Other [Self] 
 
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 
Rajat Gupta  Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh  Department of Dermatology Jawaharlal Nehru Medical College And Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH 
7454072462

grajat339@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee Jawaharlal Nehru Medical College & Hospital Faculty of Medicine Aligarh Muslim University Aligarh Uttar Pradesh   Approved 
Institutional Ethics Committee Jawaharlal Nehru Medical College & Hospital Faculty of Medicine Aligarh Muslim University Aligarh Uttar Pradesh   Approved 
Institutional Ethics Committee Jawaharlal Nehru Medical College & Hospital Faculty of Medicine Aligarh Muslim University Aligarh Uttar Pradesh   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 Clindamycin phosphate gel Topical Benzoyl Peroxide gel Topical Adapalene gel   Topical therapy every 4 weeks for 12 weeks 
Intervention  Topical Clindamycin phosphate gel Topical Benzoyl Peroxide gel Topical Adapalene gel Vs Oral Probiotic Lactobacillus rhamnosus capsule  Topical therapy Vs Topical therapy plus Oral Probiotic capsule every 4 weeks for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Age 18 to 35 years
Newly Diagnosed cases with Grade One and Grade Two Acne vulgaris
 
 
ExclusionCriteria 
Details  Severe nodulocystic acne requiring systemic isotretinoin
Grade 3 Acne vulgaris or Pustular acne requiring oral antibiotics
Antibiotic or Probiotic Therapy within the last 4 weeks
Severely immunocompromised patients
Pregnancy or lactation
Known allergy to study products
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Global Acne Grading System score between topical therapy and oral probiotic  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Dermatology Life Quality Index
Improvement in Serum Testosterone levels
Number of Adverse drug reactions 
18 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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/ Phase 4 
Date of First Enrollment (India)   15/04/2026 
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)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study aims to compare the efficacy and safety of probiotics as an add on therapy with standard topical treatment versus topical treatment alone in patients with acne vulgaris
Acne vulgaris is a common chronic inflammatory disorder of the pilosebaceous unit that significantly affects young adults and has a negative impact on quality of life
Conventional topical therapies are effective but are often associated with adverse effects and variable patient compliance
Recent evidence suggests that the gut skin axis and intestinal microbiota play an important role in acne pathogenesis which has led to growing interest in the use of probiotics as an therapeutic option
This is a prospective randomised open label parallel group controlled clinical study conducted in the Department of Pharmacology and Dermatology at Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh India
Patients aged eighteen to thirty five years with newly diagnosed Grade one and Grade two acne vulgaris will enrolled after obtaining informed consent
A total of one hundred fifty patients will be randomly divided into two groups
Group A will receive standard topical therapy while Group B will receive standard topical therapy along with oral probiotics for twelve weeks
The primary outcome measure will be the change in acne severity assessed by the Global Acne Grading System
Secondary outcome include assessment of quality of life using the Dermatology Life Quality Index and measurement of serum testosterone levels and monitoring of adverse drug reactions
Patients will be followed up at a regular intervals during the study period
The results of this study may provide evidence for a safe and patient friendly adjunctive approach in the management of acne vulgaris
 
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