Comparison of Isotretinoin alone versus Isotretinoin with Tranexamic acid in moderate to severe Acne Vulgaris

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. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105175

Enrollment

Registered

2026-03-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Oral Isotretinoin and oral tranexamic acid: capsule.ISOTRETINOIN 20 mg HS and TABLET. TRANEXAMIC ACID 250 MG BD for 12 weeks Control Intervention1: Oral Isotretinoin: CAPSULE ISOTRETINO

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed acne vulgaris of moderate to severe grade as per global acne grading system.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 . Timepoint: 4th, 8th and 12th weeks	—

Secondary

Measure	Time frame
To assess and compare the adverse effects in both the treatment groupsTimepoint: 4th,8th and 12th weeks	—

Countries

India

Contacts

Public ContactDr Sowmiya R

Government Stanley medical college and hospital

drrsowmiya@gmail.com9842403621

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026