Status:
COMPLETED
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V
Lead Sponsor:
Indonesia University
Conditions:
Melasma
Eligibility:
FEMALE
18-60 years
Phase:
NA
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...
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 les...
Eligibility Criteria
Inclusion
- aged 18 to 60 years old
- Fitzpatrick skin type IV - V
- diagnosed with melasma
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05236569
Start Date
February 1 2021
End Date
May 31 2021
Last Update
February 11 2022
Active Locations (1)
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1
Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta, DKI Jakarta, Indonesia, 10430