Melasma Clinical Trial
Official title:
The Efficacy of Oral Tranexamic Acid and a 1927 nm Diode Laser in Patients With Melasma. A Prospective Randomized Split Face Study
Tranexamic acid and 1927 diode laser non-ablative fractionated laser for the treatment of Melasma.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | October 1, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dermatology & Laser Surgery Center | Houston | Texas |
United States | Laser & Skin Surgery Center of New York | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Laser and Skin Surgery Center of New York | Dermatology & Laser Surgery Center, Houston, TX |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of mMASI (Modified Melasma Area and Severity Index) | The difference between mMASI at week 0 and mMASI at week 16 | 16 weeks |
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