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

NCT04233749 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 15107
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in Pigmentation using Colorimetry

  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

  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 Outcomes (2)

• Change in Erythema using Colorimetry

  11 visits over 270 days

• Change in Erythema using Diffuse Reflectance Spectroscopy

  11 visits over 270 days

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Tranexamic acid tablets

Interventions

Tranexamic acid tablets DRUG

325mg of tranexamic acid twice daily for six months

Also known as: Lysteda, Cyklokapron

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

New Center One

Detroit, Michigan, 48202, United States

RECRUITING

Related Publications (6)

• Bala HR, Lee S, Wong C, Pandya AG, Rodrigues M. Oral Tranexamic Acid for the Treatment of Melasma: A Review. Dermatol Surg. 2018 Jun;44(6):814-825. doi: 10.1097/DSS.0000000000001518.

  PMID: 29677015 BACKGROUND

• Ghosh A, Coondoo A. Lichen Planus Pigmentosus: The Controversial Consensus. Indian J Dermatol. 2016 Sep-Oct;61(5):482-6. doi: 10.4103/0019-5154.190108.

  PMID: 27688435 BACKGROUND

• Kanwar AJ, Dogra S, Handa S, Parsad D, Radotra BD. A study of 124 Indian patients with lichen planus pigmentosus. Clin Exp Dermatol. 2003 Sep;28(5):481-5. doi: 10.1046/j.1365-2230.2003.01367.x.

  PMID: 12950331 BACKGROUND

• Kim SJ, Park JY, Shibata T, Fujiwara R, Kang HY. Efficacy and possible mechanisms of topical tranexamic acid in melasma. Clin Exp Dermatol. 2016 Jul;41(5):480-5. doi: 10.1111/ced.12835. Epub 2016 May 2.

  PMID: 27135282 BACKGROUND

• Lee HC, Thng TG, Goh CL. Oral tranexamic acid (TA) in the treatment of melasma: A retrospective analysis. J Am Acad Dermatol. 2016 Aug;75(2):385-92. doi: 10.1016/j.jaad.2016.03.001. Epub 2016 May 17.

  PMID: 27206758 BACKGROUND

• Molinar VE, Taylor SC, Pandya AG. What's new in objective assessment and treatment of facial hyperpigmentation? Dermatol Clin. 2014 Apr;32(2):123-35. doi: 10.1016/j.det.2013.12.008.

  PMID: 24679999 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Henry W Lim, MD

  Henry Ford HS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Parks-Miller, RN

CONTACT

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

Jennifer Creasor, RN

CONTACT

1-313-916-0412; jcreaso2@hfhs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This a proof-of-concept study. Five subjects will be enrolled and all five will receive tranexamic acid.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: March 17, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)