The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans
Primary Purpose
Lichen Planus Pigmentosus, Erythema Dyschromicum Perstans, Ashy Dermatosis of Ramirez
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid tablets
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Planus Pigmentosus
Eligibility Criteria
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
Sites / Locations
- New Center OneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All five subjects will receive tranexamic acid tablets, 325mg twice daily for six months.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04233749
First Posted
January 15, 2020
Last Updated
June 22, 2023
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT04233749
Brief Title
The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans
Official Title
The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus Pigmentosus, Erythema Dyschromicum Perstans, Ashy Dermatosis of Ramirez
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This a proof-of-concept study. Five subjects will be enrolled and all five will receive tranexamic acid.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All five subjects will receive tranexamic acid tablets, 325mg twice daily for six months.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid tablets
Other Intervention Name(s)
Lysteda, Cyklokapron
Intervention Description
325mg of tranexamic acid twice daily for six months
Primary Outcome Measure Information:
Title
Change in Pigmentation using Colorimetry
Description
Determine if there is a reduction in pigmentation in patients with LPP or EDP after administration of tranexamic acid using colorimetry.
Time Frame
11 visits over 270 days
Title
Change in Pigmentation using Diffuse Reflectance Spectroscopy
Description
Determine if there is a reduction in pigmentation in patients with LPP or EDP after administration of tranexamic acid using diffuse reflectance spectroscopy.
Time Frame
11 visits over 270 days
Secondary Outcome Measure Information:
Title
Change in Erythema using Colorimetry
Description
Determine if there is a reduction in erythema in patients with LPP or EDP after administration of tranexamic acid using colorimetry.
Time Frame
11 visits over 270 days
Title
Change in Erythema using Diffuse Reflectance Spectroscopy
Description
Determine if there is a reduction in erythema in patients with LPP or EDP after administration of tranexamic acid using diffuse reflectance spectroscopy.
Time Frame
11 visits over 270 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Parks-Miller, CCRP, CWCA
Phone
1-313-916-0426
Email
amiller5@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shanthi Narla, MD
Phone
1-313-916-0412
Email
snarla1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry W Lim, MD
Organizational Affiliation
Henry Ford HS
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanthi Narla, MD
Email
snarla1@hfhs.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29677015
Citation
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.
Results Reference
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PubMed Identifier
27688435
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.
Results Reference
background
PubMed Identifier
12950331
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.
Results Reference
background
PubMed Identifier
27135282
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.
Results Reference
background
PubMed Identifier
27206758
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.
Results Reference
background
PubMed Identifier
24679999
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.
Results Reference
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Learn more about this trial
The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans
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