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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Effect of Drugs, Adverse Effects of Medical Drugs

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: 0.9% Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: individual patients were selected in study . To control over confounding factors two sides of same patient were used parallel for intradermal injection ( Mesotherapy) of tranexamic acid and with normal saline
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>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 | Drug: Tranexamic Acid<br>* Tranexamic acid intradermal injections were used for treatment of melasma<br>* Other names: Normal saline;Drug: 0.9% Normal Saline<br>* Normal saline used for comparision of efficacy of tranexamic acid<br>|
| Experimental: 0.9% Normal saline<br>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 | Drug: 0.9% Normal Saline<br>* Normal saline used for comparision of efficacy of tranexamic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melasma, Tranexamic acid, Mesotherapy