Tranexamic Acid for Skin Pigmentation Disorders

Overseen By Shanthi Narla, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Henry Ford Health System

Must not be taking: Anticoagulants, Hormonal therapy

Disqualifiers: Clotting disorder, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 24 weeks

5 Participants Needed

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.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any topical or oral medications used to treat pigmentary abnormalities at least one month before starting the trial, except for sunscreen.

Is tranexamic acid safe for use in humans?

Tranexamic acid is generally considered safe for humans and is approved for treating heavy menstrual bleeding and preventing bleeding in certain medical procedures. It has been used in dermatology for skin pigmentation disorders and studied for safety in various conditions, including heavy menstrual bleeding and knee surgery. ^{1 2 3 4 5}

How is the drug tranexamic acid unique in treating skin pigmentation disorders?

Tranexamic acid is unique because it is originally an antifibrinolytic drug used to prevent bleeding, but it has been found effective for treating skin pigmentation disorders like melasma when used orally or topically. Unlike other treatments, it offers multiple administration routes and has shown promise in enhancing the effects of laser treatments for pigmentation issues. ^{1 2 6 7 8}

What data supports the effectiveness of the drug Tranexamic Acid for skin pigmentation disorders?

Research shows that Tranexamic Acid can effectively reduce skin pigmentation in conditions like melasma, both when taken orally and applied topically. It has been used successfully in combination with other treatments, such as hydroquinone cream and laser therapy, to enhance results. ^{1 2 3 6 8}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tranexamic acid tablets, 325mg twice daily for six months

24 weeks

11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tranexamic acid

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, 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 Japan as Nicolda for:

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

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral tranexamic acid enhances the efficacy of low-fluence 1064-nm quality-switched neodymium-doped yttrium aluminum garnet laser treatment for melasma in Koreans: a randomized, prospective trial. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

Evaluation of Therapeutic Efficacy and Safety of Tranexamic Acid Local Infiltration in Combination with Topical 4% Hydroquinone Cream Compared to Topical 4% Hydroquinone Cream Alone in Patients with Melasma: A Split-Face Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Oral tranexamic acid in the treatment of hyperpigmentation disorder beyond melasma: A review. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[Oral tranexamic acid in the treatment of lichen planus pigmentosus: A prospective study of 20 cases]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid as an adjuvant treatment in melasma: Side-by-side comparison clinical study. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study. [2016]

8. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of topical versus intradermal injection of Tranexamic Acid In Egyptian melasma Patients: A randomised clinical trial. [2022]