a study to compare two treatment options for melasma.

Phase 4

Recruiting

Conditions: facial melasma

Registration Number: CTRI/2018/05/014062

Lead Sponsor: Pawan Gupta

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 Kligmanâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 60

Inclusion Criteria

All consenting male and female patients diagnosed clinically with melasma.

Exclusion Criteria

a)Pregnancy, lactation and females taking HRT/OCPâ€™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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in modified melasma area and severity index (mMASI).	4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
physicianâ€™s global assessment and patient global assessment scales, and safety assessment	12 weeks

Trial Locations

Locations (1): K.J Somaiya hospital
🇮🇳
(Suburban), MAHARASHTRA, India
K.J Somaiya hospital
🇮🇳(Suburban), MAHARASHTRA, India
Pawan Gupta
Principal investigator
8770246306
pawanguptag@gmail.com