Oral Tranexamic Acid and Laser for Treatment of Melasma

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03686787
• Other study ID #: LSSC-TA-CB-ASDS
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: September 2018
• Source: Laser and Skin Surgery Center of New York
• Contact: Jennifer Moreno
• Phone: 212-686-7306
• Email: jmoreno[@]laserskinsurgery.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Tranexamic Acid
A split face study of oral tranexamic acid in combination with laser treatment

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Laser and Skin Surgery Center of New York	Dermatology & Laser Surgery Center, Houston, TX

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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