A double arm RCT comparing the efficacy of intralesional Tranexamic acid with standard topical kligman’s regimen in patients with facial melasma.
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- improvement in modified melasma area and severity index (mMASI).
Study Overview
Brief Summary
Treatment of melasma is a real challenge due to its frequent recurrence, persistence and aggravation during or after the treatment. Hence, there has always been a need to evaluate for safe, efficacious and new therapeutic options at an affordable price to the patients without affecting their compliance to treatment.
No single treatment has been proven to be the most efficacious. In the field of dermatology, tranexamic acid (TXA) has been used as an oral agent in melasma patients for its whitening effects. However, no studies on clinical efficacy and safety of intralesional TXA for treatment of melasma patients have been reported from India till date.
This is a parallel group open- label randomized controlled trial in dermatology OPD of our hospital consisting of 60 patients of facial melasma who would randomly be divided into Group A (intralesional TXA) and Group B ( topical Kligman’s) therapy for 3 months. Modified MASI scores would be calculated at week 0, 4, 8, 12 and statistically analysed.
Therefore, we plan this study to evaluate the efficacy and safety of intralesional TXA (at interval of 2 weeks) as treatment of melasma.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All consenting male and female patients diagnosed clinically with melasma.
Exclusion Criteria
- •a)Pregnancy, lactation and females taking HRT/OCP’s b)Any severe chronic medical illness, c)Bleeding disorders or concomitant use of anticoagulants d)Any medical treatment for melasma within 1 month of entry, e)Hypersensitivity to TXA f)Abnormal bleeding time, clotting time or platelet count g)Refusal to allow photographs and Failure to finish the whole period of study would be excluded from the study.
Outcomes
Primary Outcomes
improvement in modified melasma area and severity index (mMASI).
Time Frame: 4 weeks, 8 weeks and 12 weeks
Secondary Outcomes
- physician’s global assessment and patient global assessment scales, and safety assessment(12 weeks)