- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03686787
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
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jennifer Moreno
- Phone Number: 608 212-686-7306
- Email: jmoreno@laserskinsurgery.com
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- Laser & Skin Surgery Center of New York
-
Contact:
- Jennifer Moreno
- Phone Number: 608 212-686-7306
-
Principal Investigator:
- Roy G Geronemus, M.D.
-
Sub-Investigator:
- Mitalee Christman, M.D.
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Dermatology & Laser Surgery Center
-
Contact:
- LaCresha Jackson
- Phone Number: 713-900-3900
- Email: lacresha@dermlasersurgery.com
-
Principal Investigator:
- Paul Friedman, M.D.
-
Sub-Investigator:
- Amanda Suggs, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of mMASI (Modified Melasma Area and Severity Index)
Time Frame: 16 weeks
|
The difference between mMASI at week 0 and mMASI at week 16
|
16 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSSC-TA-CB-ASDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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