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

Melasma Clinical Trial

Official title:

Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V: A Double-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236569
• Other study ID #: 20-11-1376
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: February 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Tranexamic acid injection
The tranexamic acid injection was given intradermally to the facial skin
• Injection Water
The 0.9% normal saline injection was given intradermally to the facial skin

Locations

Country	Name	City	State
Indonesia	Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Melasma Area and Severity Index (mMASI) score	Reduction of mMASI score	12 weeks
Primary	Erythema Index	Reduction of erythema index	12 weeks
Primary	Melanin Index	Reduction of melanin index	12 weeks
Secondary	Side effects	Incidence of side effects	12 weeks
Secondary	Subject's satisfaction	Satisfaction towards the treatment's results measured by patient global assessment	12 weeks