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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03686787
Other study ID # LSSC-TA-CB-ASDS
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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