The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans

June 22, 2023 updated by: Tasneem Mohammad, Henry Ford Health System
There are currently no effective treatments for lichen planus pigmentosus (LPP) and erythema dyschromicum perstans (EDP). Tranexamic acid, which may downregulate pigmentation through a reduction in plasmin, has been shown to decrease pigmentation in patients with melasma, another pigmentary disorder. Given that LPP, EDP, and melasma are all disorders of pigmentation with dermal involvement, it is possible that tranexamic acid can also reduce pigmentation in LPP and EDP as well.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lichen planus pigmentosus (LPP) and erythema dyschromicum perstans (EDP) (also known as ashy dermatosis (AD)) are two conditions on the spectrum of dermal pigmentary disorders. LPP typically affects skin phototypes III-V and has involvement of sun exposed areas or intertriginous areas. It presents as irregularly shaped or oval grey-brown macules and patches that are typically asymptomatic, but can have mild pruritus and burning. EDP, on the other hand, presents as grey-brown macules and patches in sun-protected sites and may have an early inflammatory phase with an erythematous border. It is typically asymptomatic, but can also be mildly pruritic. There is significant histologic overlap between the two conditions including basal cell degeneration, a mild perivascular or band-like infiltrate in the upper dermis, and dermal melanophages.

Multiple treatments for these conditions, including topical corticosteroids, topical calcineurin inhibitors, topical retinoids, chemical peels, minocycline, dapsone, hydroxychloroquine, isotretinoin, griseofulvin, and systemic steroids have been reported in the literature. However, none of these have been effective consistently.

Tranexamic acid (TA) is a synthetic analog of lysine, and serves as a fibrinolytic agent by binding lysine sites on fibrinogen. Commonly used in surgery to prevent bleeding, it has recently been used in dermatology for the treatment of melasma. Melasma is a pigmentary disorder characterized by hyperpigmented patches in sun-exposed areas, often in response to hormones, sunlight, and other factors. The proposed mechanism of action of tranexamic acid in decreasing pigmentation in this condition is that it decreases inflammation by decreasing dermal angiogenesis and inhibits UV induced plasmin activity in keratinocytes. Plasmin activity can increase melanogenic factors, leading to increased pigmentation. In a study by Lee et al., when administered orally at a dose of 250mg twice daily over approximately 4 months, 89.7 % of patients had documented improvement in pigmentation. Of those who improved, the median lightening was approximately 50%, which is significant. Other studies have also shown promising results.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Angela Parks-Miller, CCRP, CWCA
  • Phone Number: 1-313-916-0426
  • Email: amiller5@hfhs.org

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject age 18 and older
  • Subject with a diagnosis of LPP, EDP, or AD
  • Subject able to understand requirements of the study and risks involved
  • Subject able to sign a consent form
  • Subject to have discontinued all topical or oral medications, with the exception of sunscreen, used to treat pigmentary abnormalities one month prior to treatment

Exclusion Criteria:

  • Personal history of clotting disorder or thromboembolic disease (deep vein thrombosis (DVT), stroke, etc)
  • Active malignancy, excluding non-melanoma skin cancer
  • Moderate to severe renal impairment
  • History of migraine with aura
  • Current anticoagulant therapy
  • Current use of hormonal contraception or hormone replacement therapy in the last 30 days
  • A woman who is lactating, pregnant, or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
All five subjects will receive tranexamic acid tablets, 325mg twice daily for six months.
Drug: Tranexamic acid tablets
325mg of tranexamic acid twice daily for six months
Other Names:
  • Lysteda, Cyklokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pigmentation using Colorimetry
Time Frame: 11 visits over 270 days
Determine if there is a reduction in pigmentation in patients with LPP or EDP after administration of tranexamic acid using colorimetry.
11 visits over 270 days
Change in Pigmentation using Diffuse Reflectance Spectroscopy
Time Frame: 11 visits over 270 days
Determine if there is a reduction in pigmentation in patients with LPP or EDP after administration of tranexamic acid using diffuse reflectance spectroscopy.
11 visits over 270 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Erythema using Colorimetry
Time Frame: 11 visits over 270 days
Determine if there is a reduction in erythema in patients with LPP or EDP after administration of tranexamic acid using colorimetry.
11 visits over 270 days
Change in Erythema using Diffuse Reflectance Spectroscopy
Time Frame: 11 visits over 270 days
Determine if there is a reduction in erythema in patients with LPP or EDP after administration of tranexamic acid using diffuse reflectance spectroscopy.
11 visits over 270 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Henry W Lim, MD, Henry Ford HS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15107 (CTSRMC, Abramson Cancer Center, University of Pennsylvania)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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