Comparing efficacy of different preparations of Tranexamic Acid in the management of melasma

Phase 3

Completed

Brief Summary: Melasma is an acquired facial hypermelanosis that presents as light to dark brown macules and patches most commonly seen over sun exposed areas of face and neck. The chronic recurring nature of the disease, incomplete understanding of disease pathogenesis and unstable patient response to treatment provide a unique challenge to the treating physician. The cosmetic disfigurement caused can be socially distressing affecting patient quality of life.

Various treatment options include topical and oral medicaltions, procedures, chemical peels, Lasers and combination therapy. Tranexamic Acid has emerged as an effective treatment option finding use in topical, oral and intradermal preparations.

This randomized, prospective study aims to compare efficacy and safety of topical, oral and intradermal Tranexaic acid in the treatment of facial melasma. Study will be conducted in a tertiary care set up. Patients enrolled will be divided into 3 groups. Group A will receive topical tranexamic acid. Group B will receive oral tranexamic acid and Group C will be treated using intradermal injections of tranexamic acid. Treatment duration is months with a follow up period of 3 months.

Recruitment & Eligibility

Inclusion Criteria

All adult patients diagnosed with facial melasma.

Exclusion Criteria

Children < 18 years of age, pregnant or nursing women or women planning pregnancy during the duration of trial. Patients with Extra.
facial melasma Patient unwilling to give consent to be part of trial. Current use of oral or injectable contraceptives, hormone replacement therapy, blood thinning medications, photosensitizing drugs or drugs known to cause hyperpigmentation of skin. Current or previous use of any medical treatment (topical or oral) or cosmetic procedure (chemical peel, Laser, Dermabrasion) for melasma within 9 months of study enrollment. History of thromboembolic disease such as deep vein thrombosis (DVT), >2 spontaneous abortions, pulmonary embolism or cerebral thrombosis, stroke or subarachnoid haemorrhage. Family history of thromboembolic disease. Smoking, tobacco use. Hypersensitivity to tranexamic acid or sunscreen ingredients. Abnormal bleeding profile (PT INR, Bleeding Time, Clotting Time).

Primary Outcome Measures

Name	Time	Method
Compare efficacy of therapy with respect to decrease in size and hyperpigmentation of lesion	Calculation of modified Melasma Severity Index. \| Assessment of clinical photographs by blinded physicians by percentage response scale. \| Patient satisfaction measured according to 5 point Liker Scale. \| Measured at baseline,4 weeks, 8 weeks, 12 weeks and 3 months post treatment

Secondary Outcome Measures

Name	Time	Method
Analyze the safety and tolerability of different preparations of tranexamic acid with respect to adverse effects related to therapy	Compared during course of therapy, at end of therapy and end of post treatment follow up period.

Locations (1): Shri Bhausaheb Hire Government Medical College
🇮🇳
Dhule, MAHARASHTRA, India
Shri Bhausaheb Hire Government Medical College
🇮🇳Dhule, MAHARASHTRA, India
Dr Ashutosh Trivedi
Principal investigator
9920305434
ashutoshtrivedi7196@gmail.com