Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04233749
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2020-01-15
Brief Title:
The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 897 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
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 897 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None