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

Jinnah Postgraduate Medical Centre

Status and phase: Completed; Phase 3; Phase 2

Conditions: Effect of Drugs; Adverse Effects of Medical Drugs

Treatments: Drug: 0.9% Normal Saline; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04170088

[e-mail] (Registry Identifier)

F.2-81/2018-GENL/2522/JPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: 0.9% Normal Saline

Drug: Tranexamic Acid

0.9% Normal saline

Experimental group

Description:

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

Treatment:

Drug: 0.9% Normal Saline