Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V

NCT ID: NCT05236569

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-05-31

Brief Summary

A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.

Detailed Description

All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face.

The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI).

Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic acid

The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.

Group Type: EXPERIMENTAL

Tranexamic acid injection

Intervention Type: DRUG

The tranexamic acid injection was given intradermally to the facial skin

Placebo

The placebo was 1 ml of 0.9% normal saline which was given intradermally.

Group Type: PLACEBO_COMPARATOR

Injection Water

Intervention Type: DRUG

The 0.9% normal saline injection was given intradermally to the facial skin

Interventions

Tranexamic acid injection

The tranexamic acid injection was given intradermally to the facial skin

Intervention Type: DRUG

Injection Water

The 0.9% normal saline injection was given intradermally to the facial skin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• aged 18 to 60 years old
• Fitzpatrick skin type IV - V
• diagnosed with melasma

Exclusion Criteria

• pregnancy and breastfeeding
• use of oral contraceptives within six months
• use of topical or systemic melasma therapy within two weeks
• history of superficial peeling within four weeks
• history of dermabrasion within six months
• use of photosensitizer drugs
• history of thrombosis or currently using antithrombotic or anticoagulant drugs
• history of TA allergy
• experiencing any COVID-19 symptoms

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Vashty Amanda Hosfiar

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

20-11-1376

Identifier Type: -

Identifier Source: org_study_id