What is the mechanism of action of this treatment?

Lichen Planus Pigmentosus (LPP) is a challenging pigmentary disorder with limited effective treatments. Tranexamic Acid (TA) has shown promise by inhibiting plasmin activity, which reduces melanogenesis and pigmentation. This mechanism is crucial for LPP patients as it targets the biochemical pathways responsible for excessive pigmentation, offering a potential therapeutic approach to manage and reduce the pigmentation associated with LPP.

What side effects are associated with this type of intervention?

Common treatments for Lichen Planus Pigmentosus (LPP) include tranexamic acid, which may cause gastrointestinal disturbances like nausea and diarrhea, and carries a risk of thromboembolic events. Hydroquinone, another treatment, can lead to skin irritation, contact dermatitis, and ochronosis with long-term use. Chemical peels and laser therapies, often used for pigmentation disorders, may result in temporary redness, swelling, and a risk of post-inflammatory hyperpigmentation or scarring.

What prior FDA approvals exist?

There are currently no FDA-approved treatments specifically for Lichen Planus Pigmentosus (LPP). However, Tranexamic Acid, which reduces pigmentation by downregulating plasmin, has shown promise in treating other pigmentary disorders like melasma. This suggests potential efficacy for LPP, although it has not yet received FDA approval for this specific condition.

What other types of research exist?

Promising novel alternatives to Tranexamic Acid for Lichen Planus Pigmentosus patients include JAK inhibitors, such as Tofacitinib, which have shown efficacy in reversing conditions driven by cytotoxic T lymphocytes and pigmentation disorders. Additionally, treatments like photodynamic therapy (PDT) with agents such as aminolevulinate or methyl aminolevulinate, which are effective in other skin conditions, may also be considered.

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Anti-fibrinolytic agent

Tranexamic Acid for Skin Pigmentation Disorders

Phase 2

Recruiting

Led By Henry W Lim, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject with a diagnosis of LPP, EDP, or AD

Subject age 18 and older

Must not have

Current anticoagulant therapy

Active malignancy, excluding non-melanoma skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 11 visits over 270 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Tranexamic acid may cause side effects such as nausea, diarrhea, stomach pain; less commonly it could increase clotting risks leading to serious events like deep vein thrombosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on blood thinner medication.

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I have an active cancer other than non-melanoma skin cancer.

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I have a history of blood clots or stroke.

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My kidneys do not work well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 11 visits over 270 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~11 visits over 270 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 visits over 270 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pigmentation using Colorimetry

Change in Pigmentation using Diffuse Reflectance Spectroscopy

Secondary study objectives

Change in Erythema using Colorimetry

Change in Erythema using Diffuse Reflectance Spectroscopy

Side effects data

From 2008 Phase 3 trial • 196 Patients • NCT00386308

59%

Headache

37%

Nasal & Sinus Symptoms

24%

Back Pain

20%

Abdominal Pain

11%

Musculoskeletal Pain

10%

Anemia

Arthralgia

Muscle Cramps & Spasms

Fatigue

Migraine

Decreased Blood Sugar

Tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

3900 mg/Day

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid tablets

2006

Completed Phase 3

~590

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lichen Planus Pigmentosus (LPP) is a challenging pigmentary disorder with limited effective treatments. Tranexamic Acid (TA) has shown promise by inhibiting plasmin activity, which reduces melanogenesis and pigmentation. This mechanism is crucial for LPP patients as it targets the biochemical pathways responsible for excessive pigmentation, offering a potential therapeutic approach to manage and reduce the pigmentation associated with LPP.

Comparison of clinical results of oral tranexamic acid and platelet rich plasma therapies in melasma treatment.Laser-assisted delivery of tranexamic acid for melasma: Pilot study using a novel 1927 nm fractional thulium fiber laser.A Prospective Randomized Controlled Study of Oral Tranexamic Acid for the Prevention of Postinflammatory Hyperpigmentation After Q-Switched 532-nm Nd:YAG Laser for Solar Lentigines.