| 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
|
|
|
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
|
|
|
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 |