Tranexamic Acid for Skin Pigmentation Disorders

Recruiting in Palo Alto (17 mi)

Overseen by Henry W Lim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Henry Ford Health System

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing tranexamic acid, a medication that can lighten dark patches on the skin, on patients with lichen planus pigmentosus (LPP) and erythema dyschromicum perstans (EDP). These patients have not found consistent relief with other treatments. Tranexamic acid works by reducing inflammation and blocking processes that cause the skin to darken. It is increasingly recognized for its utility in treating various skin conditions, including melasma and post-inflammatory hyperpigmentation.

Research Team

Henry W Lim, MD

Principal Investigator

Henry Ford HS

Eligibility Criteria

This trial is for adults over 18 with Lichen Planus Pigmentosus or Erythema Dyschromicum Perstans, who haven't used any treatments except sunscreen in the last month. It's not for those on blood thinners, hormone therapies recently, with a history of clots or severe kidney issues, active cancers (except skin cancer), migraines with aura, or women who are pregnant or breastfeeding.

Inclusion Criteria

I have been diagnosed with LPP, EDP, or AD.

Subject able to sign a consent form

I understand what participating in the study involves and its risks.

Exclusion Criteria

You have experienced migraines accompanied by symptoms like visual disturbances.

I am currently on blood thinner medication.

I have used hormonal contraception or hormone therapy in the past month.

Treatment Details

Interventions

• Tranexamic acid (Anti-fibrinolytic agent)

Trial Overview The study tests if Tranexamic acid tablets can help reduce skin pigmentation in conditions like LPP and EDP by possibly affecting plasmin levels which are involved in pigmentation. There's no current effective treatment for these conditions.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All five subjects will receive tranexamic acid tablets, 325mg twice daily for six months.

Tranexamic acid is already approved in United States, European Union, Australia, Japan for the following indications:

🇺🇸 Approved in United States as Lysteda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma

🇪🇺 Approved in European Union as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

🇦🇺 Approved in Australia as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

🇯🇵 Approved in Japan as Nicolda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

New Center One Detroit, MI

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Patients Recruited

2,197,000+