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
1 other identifier
interventional
32
1 country
2
Brief Summary
Tranexamic acid and 1927 diode laser non-ablative fractionated laser for the treatment of Melasma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2018
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
September 27, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedSeptember 27, 2018
September 1, 2018
10 months
September 25, 2018
September 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of mMASI (Modified Melasma Area and Severity Index)
The difference between mMASI at week 0 and mMASI at week 16
16 weeks
Interventions
A split face study of oral tranexamic acid in combination with laser treatment
Eligibility Criteria
You may qualify if:
- Age 18 to 50 Skin types I through VI (all skin types) Moderate or severe melasma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Laser & Skin Surgery Center of New York
New York, New York, 10016, United States
Dermatology & Laser Surgery Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2018
First Posted
September 27, 2018
Study Start
October 1, 2018
Primary Completion
July 31, 2019
Study Completion
October 1, 2019
Last Updated
September 27, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share