Title
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
Phase
Phase 2/Phase 3Lead Sponsor
Jinnah Postgraduate Medical CentreStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Adverse Effects of Medical Drugs Effect of DrugsIntervention/Treatment
Tranexamic Acid 0.9% Normal SalineStudy Participants
30It 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.
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.
Tranexamic acid intradermal injections were used for treatment of melasma
Normal saline used for comparision of efficacy of tranexamic acid
Left side of face of each participant was selected for intradermal Tranexamic acid injections. generic name : Tranexamic acid Dose : 4mg / ml tranexamc acid diluted with 0.9 % normal saline Frequency : every 2 weekly total 6 doses. Duration : 6 months
Right side of face of each participant was selected for intradermal normal saline injections generic name : Normal Saline Dose : 0.9 % Normal Saline Dose : Frequency : every 2 weekly total 6 doses. Duration : 6 months
Inclusion Criteria: informed consent age between 18 to 55 years bilateral symmetrical mild to severe melasma Exclusion Criteria: pregnancy and lactation history of taken any topical treatment for melasma in previous 1 month history of bleeding disorders concomitant use of anticoagulants, any known drug allergy especially to the study drug, having associated medical illnesses.
