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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06010810

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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:

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?
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?
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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: 3 % Topical Tranexamic Acid Drug: 4% Topical Hidroquinone	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 % Topical Tranexamic Acid Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months	Drug: 3 % Topical Tranexamic Acid Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months Drug: 4% Topical Hidroquinone Patient will be given 3% Topical Hidroquinone, on half of the face, twice a day for 2 months
Experimental: 4 % Topical Hydroquinone Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.	Drug: 3 % Topical Tranexamic Acid Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months Drug: 4% Topical Hidroquinone Patient will be given 3% Topical Hidroquinone, on half of the face, twice a day for 2 months

Arm

Intervention/Treatment

Experimental: 3 % Topical Tranexamic Acid

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

Drug: 3 % Topical Tranexamic Acid

Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months

Drug: 4% Topical Hidroquinone

Patient will be given 3% Topical Hidroquinone, on half of the face, twice a day for 2 months

Experimental: 4 % Topical Hydroquinone

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

Drug: 3 % Topical Tranexamic Acid

Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months

Drug: 4% Topical Hidroquinone

Patient will be given 3% Topical Hidroquinone, on half of the face, twice a day for 2 months

Outcome Measures

Primary Outcome Measures

mMasi score [2 months]
Decrease in mMasi score
Mexameter score [2 months]
Decrease in Mexamater score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangungkusumo Hospital	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

Principal Investigator: Nevi Yasnova, MD, Faculty of medicine, University of Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nevi Yasnova, Medical Doctor, Indonesia University

ClinicalTrials.gov Identifier:

NCT06010810

Other Study ID Numbers:

23040463

First Posted:

Aug 25, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanosis

Tranexamic Acid

Study Results

No Results Posted as of Aug 25, 2023