Oral and Topical Tranexamic Acid for the Treatment of Melasma

NCT03585179 | Unknown Phase 3 FDA Drug

• 1 other identifier: 151/2018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melasma; Chloasma; Melanosis

Keywords

Melasma; Chloasma; Melanosis; Tranexamic acid; Hydroquinone; Therapeutics

Outcome Measures

Primary Outcomes (1)

• Change of mMASI (Modified Melasma Area and Severity Index)

  The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12

  12 weeks

Secondary Outcomes (2)

• Change in Quality of life

  12 weeks

• Melanin index

  12 weeks

Study Arms (3)

Oral tranexamic acid

EXPERIMENTAL

250 mg of tranexamic acid bid orally

Drug: Oral Tranexamic Acid

Topical tranexamic acid

EXPERIMENTAL

5% topical tranexamic acid bid

Drug: 5% topical tranexamic acid

Topical hydroquinone

ACTIVE COMPARATOR

4% hydroquinone once daily at night

Drug: 4% hydroquinone

Interventions

Oral Tranexamic Acid DRUG

Participants will take a pill of 250 mg bid for 12 weeks

Oral tranexamic acid

5% topical tranexamic acid DRUG

Participants will apply a layer of gel on the affected skin bid for 12 weeks

Also known as: Topical tranexamic acid

Topical tranexamic acid

4% hydroquinone DRUG

Participants will apply a layer of cream on the affected skin once at night

Also known as: Hydroquinone

Topical hydroquinone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age older than 18 years
• Moderate to severe melasma
• History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI \<50% reported by the dermatologist after one year of treatment.

You may not qualify if:

• Pregnancy
• Hormonal contraception
• Lactation
• Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months
• Endocrinology diseases
• Hormone replacement therapy
• Family or personal history of one of the following: autoimmune disorders, coagulation disorders, chronic venous insufficiency, heart diseases, retinopathies, kidney disorders
• Mental disability

Sponsors & Collaborators

• Centro Dermatológico Dr. Ladislao de la Pascua: lead

Study Sites (1)

Centro Dermatológico "Dr. Ladislao de la Pascua"

Mexico City, 06780, Mexico

Location

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid; hydroquinone

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 Officials

• Martha A Morales-Sánchez, MD

  Centro Dermatológico Dr. Ladislao de la Pascua

  STUDY DIRECTOR

Central Study Contacts

Martha A Morales-Sánchez, MD

CONTACT

55387033; mmoraless@sersalud.df.gob.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will receive both topical and oral interventions. Group 1: pills of tranexamic acid 250 mg bid plus placebo gel bid, Group 2: pills of placebo bid plus 5% tranexamic acid gel bid and Group 3: pills of placebo bid plus 4% hydroquinone cream at night and a placebo cream at morning. Containers will be of identical appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm clinical trial

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2020
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)