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

Lichen Planus Pigmentosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233749
• Other study ID #: 15107
• Status: Recruiting
• Phase: Phase 2
• Start date: March 17, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Henry Ford Health System
• Contact: Angela Parks-Miller, CCRP, CWCA
• Phone: 1-313-916-0426
• Email: amiller5[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ashy Dermatosis of Ramirez
• Erythema
• Erythema Dyschromicum Perstans
• Lichen Planus
• Lichen Planus Pigmentosus
• Skin Diseases

Intervention

Drug:
• Tranexamic acid tablets
325mg of tranexamic acid twice daily for six months

Locations

Country	Name	City	State
United States	New Center One	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Erythema using Colorimetry	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
Secondary	Change in Erythema using Diffuse Reflectance Spectroscopy	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