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

Jinnah Postgraduate Medical Centre30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Effect of Drugs Adverse Effects of Medical Drugs

Interventions

Tranexamic AcidDRUG

Tranexamic acid intradermal injections were used for treatment of melasma

0.9% Normal SalineDRUG

Normal saline used for comparision of efficacy of tranexamic acid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Change in HEMI-Modified Melasma Area and Severity Index (mMASI)

Calculation of Hemi mMASI score is performed by rating darkness and area of involvement of 3 areas of the each half of face. These figures are then inserted into an equation, resulting in the final Hemi mMASI score for both halves of face. Equation : forehead (0.15×D×A) + malar ( 0.30×D×A) + chin ( 0.05×D×A) The mean value of the data obtained from each half of the face was calculated and the mean percentage change was compared. Hemi-MASI score was used because of the study design of split-face, and it was calculated based on the percentage of the involved area Improvement was considered when there was reduction in mean hemi modified MASI score at both sides of face. Higher score was considered as worse and low score was considered as good in improvement of melasma. At each follow-up visit, adverse events were also evaluated. Patients were asked to reports side effects such as erythema, burning, swelling, and change in menstrual cycle during and after treatment.

Time frame: 10 months

Data from ClinicalTrials.gov

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