Recruiting
Phase 2

Tranexamic Acid

Sponsor:

Henry Ford Health System

Code:

NCT04233749

Conditions

Lichen Planus Pigmentosus

Erythema Dyschromicum Perstans

Ashy Dermatosis of Ramirez

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic acid tablets

Study Details

Brief summary:

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.

Conditions

Lichen Planus Pigmentosus

Erythema Dyschromicum Perstans

Ashy Dermatosis of Ramirez

Study ID

NCT04233749

Start date

Mar 17, 2020

Status verified date

Sep, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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

Interventions

Tranexamic acid tablets

325mg of tranexamic acid twice daily for six months

Primary outcome measure

  • Change in Pigmentation using Colorimetry [ Time Frame: 11 visits over 270 days ]
  • Change in Pigmentation using Diffuse Reflectance Spectroscopy [ Time Frame: 11 visits over 270 days ]

Central Contacts and Locations

Central contacts

Angela Parks-Miller, RN

1-313-916-0426amiller5@hfhs.org

Locations

New Center One

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Jennifer Creasor, RN

jcreaso2@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2025-09-09.