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Clinical Trials/NCT06010810
NCT06010810Active, not recruitingPhase 3

The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma

Indonesia University1 site in 1 country20 target enrollmentStarted: June 1, 2023Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Enrollment
20
Locations
1
Primary Endpoint
Modified Melasma Area and Severity Index
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The goal of this clinical trial is to compare 3% Topical Tranexamic Acid with 4% Topical Hydroquinone as Therapy of Melasma in Patients with Skin Type III-V. The main question[s] it aims to answer are:

  1. Is there a greater decrease in mMASI score after application of 3% topical tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V?
  2. Is there a greater decrease in mexameter score after application of 3% topical tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V?
  3. Are there any side effects of topical therapy of 3% tranexamic acid cream on melasma patients with skin types III - V? Participants with melasma diagnostic will apply the tranexamic acid cream and hydroquinone cream on both sides of the face differently. Researchers will compare by measuring the mexameter score and mMasi score to see if there any decrease in both sides of the face.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Female patients diagnosed with melasma.
  • •18-60 years old.
  • •Fitzpatrick skin type III to V.
  • •Willing to be a research subject (SP) and sign a consent sheet. research (informed consent).

Exclusion Criteria

  • •Are pregnant and/or breastfeeding
  • •History of taking hormonal contraceptives in the last 6 months
  • •History of topical melasma therapy: corticosteroids, tretinoin, hydroquinone, and Another therapy that lightens the skin in the last 2 weeks.
  • •Use oral systemic therapy or injection in melasma, such as oral acid tranexamic, oral antioxidant, vitamin C injection, and glutathione injection in 4 last week.
  • •History of superficial peeling therapy in the last 4 weeks.
  • •History of deep peeling, laser or mechanical abrasion therapy in the last 6 months.
  • •Use drugs that are photosensitizers such as phenytoin, tetracycline, spironolactone, and carbamazepine.
  • •History of bleeding disorders or being on blood-thinning therapy
  • •Allergy to tranexamic acid
  • •Difficulty in complying with treatment.
  • •Are experiencing symptoms of COVID-19, such as fever, cough, sore throat, loss of sense of taste or smell, red eyes, diarrhea, rash on the skin

Arms & Interventions

3 % Topical Tranexamic Acid

Experimental

Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months

Intervention: 3 % Topical Tranexamic Acid (Drug)

4 % Topical Hydroquinone

Experimental

Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.

Intervention: 4% Topical Hidroquinone (Drug)

Outcomes

Primary Outcomes

Modified Melasma Area and Severity Index

Time Frame: 2 months

Decrease of Modified Melasma Area and Severity Index

Mexameter score

Time Frame: 2 months

Decrease of melanin index and erythema index

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nevi Yasnova

Medical Doctor

Indonesia University

Study Sites (1)

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The Effectiveness of 3% Topical Tranexamic... | Clinical Trial