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

NCT05236569 | Completed DMC

• 1 other identifier: 20-11-1376
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

melasma; tranexamic acid; modified melasma area and severity index; melanin index; erythema index

Outcome Measures

Primary Outcomes (3)

• Modified Melasma Area and Severity Index (mMASI) score

  Reduction of mMASI score

  12 weeks

• Erythema Index

  Reduction of erythema index

  12 weeks

• Melanin Index

  Reduction of melanin index

  12 weeks

Secondary Outcomes (2)

• Side effects

  12 weeks

• Subject's satisfaction

  12 weeks

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic acid injection

Placebo

PLACEBO COMPARATOR

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

Drug: Injection Water

Interventions

Tranexamic acid injection DRUG

The tranexamic acid injection was given intradermally to the facial skin

Tranexamic acid

Injection Water DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

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

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, care provider, outcomes assessor, and subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Eligible subjects were randomized to receive either 10 mg of intradermal tranexamic acid injection or placebo on one side of the face with 1:1 ratio. The allocation sequence was generated with a computer by an analyst.

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 11, 2022
• Study Start: February 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)