NCT04170088

Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma

Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma; a Split Face Study in Tertiary Care Hospital of Karachi

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Jinnah Postgraduate Medical Centre · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.

Detailed description

In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value \< 0.01 was taken significant.

Conditions

• Effect of Drugs
• Adverse Effects of Medical Drugs

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Tranexamic acid intradermal injections were used for treatment of melasma
DRUG	0.9% Normal Saline	Normal saline used for comparision of efficacy of tranexamic acid

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-05-01
• Completion: 2019-06-30
• First posted: 2019-11-20
• Last updated: 2019-12-17

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study