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Oral Tranexamic Acid and Laser for Treatment of Melasma

Primary Purpose

Melasma

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Laser and Skin Surgery Center of New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring melasma, chloasma, tranexamic acid, nonablative laser resurfacing, sunscreen, hyperpigmentation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laser & Skin Surgery Center of New YorkRecruiting
  • Dermatology & Laser Surgery CenterRecruiting

Outcomes

Primary Outcome Measures

Change of mMASI (Modified Melasma Area and Severity Index)
The difference between mMASI at week 0 and mMASI at week 16

Secondary Outcome Measures

Full Information

First Posted
September 25, 2018
Last Updated
September 25, 2018
Sponsor
Laser and Skin Surgery Center of New York
Collaborators
Dermatology & Laser Surgery Center, Houston, TX
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1. Study Identification

Unique Protocol Identification Number
NCT03686787
Brief Title
Oral Tranexamic Acid and Laser for Treatment of Melasma
Official Title
The Efficacy of Oral Tranexamic Acid and a 1927 nm Diode Laser in Patients With Melasma. A Prospective Randomized Split Face Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laser and Skin Surgery Center of New York
Collaborators
Dermatology & Laser Surgery Center, Houston, TX

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
melasma, chloasma, tranexamic acid, nonablative laser resurfacing, sunscreen, hyperpigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Healthy, non-smoking
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
1927 nm nonablative laser
Intervention Description
A split face study of oral tranexamic acid in combination with laser treatment
Primary Outcome Measure Information:
Title
Change of mMASI (Modified Melasma Area and Severity Index)
Description
The difference between mMASI at week 0 and mMASI at week 16
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Moreno
Phone
212-686-7306
Ext
608
Email
jmoreno@laserskinsurgery.com
Facility Information:
Facility Name
Laser & Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Moreno
Phone
212-686-7306
Ext
608
First Name & Middle Initial & Last Name & Degree
Roy G Geronemus, M.D.
First Name & Middle Initial & Last Name & Degree
Mitalee Christman, M.D.
Facility Name
Dermatology & Laser Surgery Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaCresha Jackson
Phone
713-900-3900
Email
lacresha@dermlasersurgery.com
First Name & Middle Initial & Last Name & Degree
Paul Friedman, M.D.
First Name & Middle Initial & Last Name & Degree
Amanda Suggs, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.laserskinsurgery.com
Description
Related Info

Learn more about this trial

Oral Tranexamic Acid and Laser for Treatment of Melasma

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