NCT03585179 (TRANEXAMICO) is a Phase 3 clinical trial of Oral Tranexamic Acid in Melasma, sponsored by Centro Dermatológico Dr. Ladislao de la Pascua.

Who is sponsoring NCT03585179?

NCT03585179 is sponsored by Centro Dermatológico Dr. Ladislao de la Pascua.

What drugs are being tested in NCT03585179?

Interventions in NCT03585179: Oral Tranexamic Acid, 5% topical tranexamic acid, 4% hydroquinone.

What condition does NCT03585179 study?

NCT03585179 studies Melasma, Chloasma, Melanosis.

Is NCT03585179 still recruiting?

NCT03585179 is currently status unknown. Last updated 16 July 2018.

Last reviewed 2018-07-16 · How we verify

NCT03585179: TRANEXAMICO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oral and Topical Tranexamic Acid for the Treatment of Melasma

Status unknown Phase 3 Last updated 16 July 2018

What this trial tests

Phase 3 trial testing Oral Tranexamic Acid in Melasma in 120 participants. Status unknown.

Timeline

1 August 2018

Primary endpoint
31 December 2019

1 June 2020

Quick facts

Lead sponsor	Centro Dermatológico Dr. Ladislao de la Pascua
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	120
Start date	1 August 2018
Primary completion	31 December 2019
Estimated completion	1 June 2020
Sites	1 location across Mexico

Drugs / interventions tested

Oral Tranexamic Acid
5% topical tranexamic acid — full drug profile →
4% hydroquinone

Conditions studied

Melasma — all drugs for Melasma →
Chloasma — all drugs for Chloasma →
Melanosis — all drugs for Melanosis →

Sponsor

Centro Dermatológico Dr. Ladislao de la Pascua

Who can join

Adults 18 to 60, any sex, with Melasma or Chloasma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Oral Tranexamic Acid

Trials testing the same drug.

NCT03365999 — Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement. · Phase 2 · completed

Other recruiting trials for Melasma

Currently open trials in the same condition.

NCT06845540 — Oral Metformin for Treating Melasma in Latin American Women · Phase 1, PHASE2 · recruiting
NCT06644157 — Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser · NA · active not recruiting
NCT07034560 — Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma · Phase 4 · active not recruiting
NCT06516419 — Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy · NA · recruiting
NCT05942248 — The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis · NA · recruiting

Other Centro Dermatológico Dr. Ladislao de la Pascua trials

Trials by the same sponsor.

NCT04290572 — Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts · Phase 3 · unknown
NCT02823236 — Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars · Phase 3 · unknown
NCT03585140 — Low Glycemic Index and Load Diet for the Treatment of Acne · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03585179 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centro Dermatológico Dr. Ladislao de la Pascua
Last refreshed: 16 July 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03585179.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing