Oral Tranexamic Acid and Laser for Treatment of Melasma

Phase 4

• Conditions: Melasma

• Registration Number: NCT03686787
• Lead Sponsor: Laser and Skin Surgery Center of New York

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-25
• Study First Posted: 2018-09-27
• Last Update Posted: 2018-09-27
• Study Start: 2018-10-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (2)

Laser & Skin Surgery Center of New York; 🇺🇸 New York, New York, United States

Dermatology & Laser Surgery Center; 🇺🇸 Houston, Texas, United States