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CTRI Number  CTRI/2026/03/105175 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Isotretinoin alone versus Isotretinoin with Tranexamic acid in moderate to severe Acne Vulgaris 
Scientific Title of Study   A comparative study to assess the efficacy of oral Isotretinoin alone versus combination of oral Isotretinoin with oral Tranexamic acid in moderate to severe Acne vulgaris. 
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 Durga S 
Designation  Postgraduate resident  
Affiliation  Government Stanley medical college and hospital  
Address  Room no- 81, Department of DVL, Super speciality block, Government Stanley medical college and hospital, Chennai.

Chennai
TAMIL NADU
600001
India 
Phone  9600327467  
Fax    
Email  durgasellamuthu77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sowmiya R 
Designation  Associate professor  
Affiliation  Government Stanley medical college and hospital  
Address  Room no- 81, Department of DVL, Super speciality block, Government Stanley medical college and hospital, Chennai.

Chennai
TAMIL NADU
600001
India 
Phone  9842403621  
Fax    
Email  drrsowmiya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sowmiya R  
Designation  Associate professor  
Affiliation  Government Stanley medical college and hospital  
Address  Room no- 81, Department of DVL, Super speciality block, Government Stanley medical college and hospital, Chennai.

Chennai
TAMIL NADU
600001
India 
Phone  9842403621  
Fax    
Email  drrsowmiya@gmail.com  
 
Source of Monetary or Material Support  
Government Stanley medical college and hospital  
 
Primary Sponsor  
Name  Dr Durga S 
Address  Room no- 81, Department of DVL, Super speciality block, Government Stanley medical college and hospital, Chennai, Tamilnadu, India-600001 
Type of Sponsor  Government medical college 
 
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 Durga S  Government Stanley medical college and hospital   Room no-81, Department of DVL, Super speciality block,
Chennai
TAMIL NADU 		 9600327467

durgasellamuthu77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govenment stanley medical college and hospital, Chennai  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  Oral Isotretinoin  CAPSULE ISOTRETINOIN 20MG HS for 12 weeks 
Intervention  Oral Isotretinoin and oral tranexamic acid  capsule.ISOTRETINOIN 20 mg HS and TABLET. TRANEXAMIC ACID 250 MG BD for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  Clinically diagnosed acne vulgaris of moderate to severe grade as per global acne grading system.
 
 
ExclusionCriteria 
Details  History of thromboembolic disease or bleeding disorder.
Use of anticoagulants or hormonal therapy.
Hypersensitivity / intolerance to Isotretinoin / Tranexamic acid .
Uncontrolled dyslipidemia.
Significant cardiac, hepatic or renal or CNS impairment.
Known psychiatric disorder.
History of intracranial hypertension. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of oral tranexamic acid as an adjuvant therapy in moderate to severe acne vulgaris.
To assess and compare the reduction in acne severity using GAGS.
To evaluate the improvement in post acne erythema and pigmentation .

 		 4th, 8th and 12th weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the adverse effects in both the treatment groups  4th,8th and 12th weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   20/03/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit and is one of the most common dermatological conditions affecting adolescents and young adults. Moderate to severe acne can lead to scarring, post-inflammatory erythema, hyperpigmentation, and significant psychosocial distress.

Oral isotretinoin is considered the gold standard treatment for moderate to severe acne vulgaris due to its sebosuppressive, comedolytic, and anti-inflammatory properties. However, despite adequate isotretinoin therapy, some patients continue to experience persistent inflammatory lesions, erythema, and post-inflammatory hyperpigmentation.

Tranexamic acid is an antifibrinolytic agent that has demonstrated anti-inflammatory, anti-angiogenic, and pigmentation-reducing properties and has been used safely in dermatological conditions such as melasma and rosacea. Its role as an adjuvant therapy in acne vulgaris may enhance treatment response and improve post-acne erythema and pigmentation.

This study aims to compare the efficacy and safety of oral isotretinoin alone versus oral isotretinoin combined with oral tranexamic acid in the treatment of moderate to severe acne vulgaris.

Public Health Relevance

The study may help identify whether adding oral tranexamic acid to standard isotretinoin therapy provides superior clinical improvement in acne severity and post-acne pigmentation without increasing adverse effects. The findings could contribute to optimizing treatment strategies for moderate to severe acne vulgaris.

 Title of the Study

A comparative study to assess the efficacy of oral isotretinoin alone versus combination of oral isotretinoin with oral tranexamic acid in moderate to severe acne vulgaris.

Study Design

This is a randomized, parallel-group, open-label, active-controlled clinical trial.

Study Setting

Department of Dermatology, Venereology and Leprology, Government Stanley Medical College and Hospital, Chennai, Tamil Nadu, India.

Study Population

Male patients aged 18–35 years with clinically diagnosed moderate to severe acne vulgaris attending the dermatology outpatient department.

Intervention and Comparator

Group A (Control group): Oral isotretinoin  alone for 12 weeks

Group B (Intervention group): Oral isotretinoin in combination with oral tranexamic acid for 12 weeks

Participants will be randomly allocated into either group and followed up for assessment of treatment outcomes every 2 weeks from onset of treatment upto 20 weeks.

Outcome Measures

Primary Outcome:

Reduction in acne severity assessed using the Global Acne Grading System (GAGS).

Secondary Outcomes:

Improvement in post-inflammatory hyperpigmentation.

Improvement in acne-associated erythema.

Assessment and comparison of adverse effects in both treatment groups.

Duration of Study

Each participant will be followed for approximately 20 weeks, including treatment and post-treatment follow-up.

Sample Size

A total of 50 participants will be enrolled, with 25 participants in each study group.

Ethical Considerations

Written informed consent will be obtained from all participants prior to enrollment. Participation is voluntary, and participants may withdraw from the study at any time without affecting their routine medical care. Patient confidentiality will be strictly maintained. All adverse events will be monitored and managed appropriately as per institutional ethical guidelines.

 
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