Oral Tranexamic Acid and Laser for Treatment of Melasma

The Efficacy of Oral Tranexamic Acid and a 1927 nm Diode Laser in Patients With Melasma. A Prospective Randomized Split Face Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03686787

Enrollment

Registered

2018-09-27

Start date

2018-10-01

Completion date

2019-10-01

Last updated

2018-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Keywords

melasma, chloasma, tranexamic acid, nonablative laser resurfacing, sunscreen, hyperpigmentation

Brief summary

Tranexamic acid and 1927 diode laser non-ablative fractionated laser for the treatment of Melasma.

Detailed description

Seeking healthy non-smoking male and female volunteers of all skin types of age 18 to 50 with moderate melasma or severe melasma. Participants will receive up to 5 monthly laser treatments to half the face and need to take a pill twice a day for 4 months. Follow up visits are required 1 month, 3 months and 6 months after the final treatment. Compensation of up to $150 will be provided based on completed visits.

Interventions

DRUGTranexamic Acid

A split face study of oral tranexamic acid in combination with laser treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Healthy, non-smoking

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Age 18 to 50 Skin types I through VI (all skin types) Moderate or severe melasma

Exclusion criteria

Pregnant or nursing women Current use of hormonal birth control medication or any hormonal therapy Use of topical steroids within 1 month of study enrollment Use of topical hydroquinone within 3 months of study enrollment History of laser or dermabrasion to the face within 6 months of study enrollment Regular use of tanning parlors Occupation involving primarily outdoor activities Current treatment with blood thinning medications History of thrombosis or thrombophilia History of thromboembolic disease, such as deep vein thrombosis, pulmonary embolism and/or cerebral thrombosis Family history of thromboembolic disease History of stroke History of \>2 spontaneous abortions History of kidney dysfunction History of cancer Smoking Significant cardiovascular or respiratory disease (end-stage congestive heart failure or chronic obstructive pulmonary disease) History of subarachnoid hemorrhage History of acquired disturbances of color vision Known allergy to tranexamic acid As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Design outcomes

Primary

Measure	Time frame	Description
Change of mMASI (Modified Melasma Area and Severity Index)	16 weeks	The difference between mMASI at week 0 and mMASI at week 16

Countries

United States

Contacts

Primary ContactJennifer Moreno

jmoreno@laserskinsurgery.com212-686-7306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026