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.

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.