Tranexamic Acid for Skin Pigmentation Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests tranexamic acid to determine its effectiveness in reducing skin discoloration in individuals with specific pigmentation disorders, namely lichen planus pigmentosus (LPP) and erythema dyschromicum perstans (EDP). Tranexamic acid has shown promise in treating melasma, another skin discoloration condition, and researchers hope for similar results with LPP and EDP. Participants will take tranexamic acid tablets twice daily for six months. Individuals with LPP or EDP who have discontinued other skin treatments, except sunscreen, for a month may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any topical or oral medications used to treat pigmentary abnormalities at least one month before starting the trial, except for sunscreen.
Is there any evidence suggesting that tranexamic acid is likely to be safe for humans?
Research has shown that tranexamic acid is generally well-tolerated. Studies have demonstrated its safety when used for melasma, a skin pigmentation issue similar to the conditions studied in this trial. Long-term studies on tranexamic acid tablets have indicated that the treatment is mostly safe for people using it for other conditions, like heavy menstrual bleeding.
While side effects can occur, they are usually mild. Some individuals might experience an upset stomach or headaches. Tranexamic acid already has FDA approval for other uses, suggesting a good safety record. This approval indicates thorough safety testing in humans. However, as with any treatment, potential risks should be discussed with a healthcare provider before deciding to join a trial.12345Why do researchers think this study treatment might be promising for skin pigmentation disorders?
Tranexamic acid is unique because it tackles skin pigmentation disorders by inhibiting the production of melanin, the pigment responsible for skin color. This mechanism is different from standard treatments like hydroquinone or corticosteroids, which often focus on reducing inflammation or lightening skin through other pathways. Researchers are excited about tranexamic acid because it offers a novel approach by directly interfering with melanin synthesis, potentially providing a more targeted and effective solution for pigmentation issues. Additionally, tranexamic acid has the advantage of being administered orally, which might be more convenient compared to topical treatments.
What evidence suggests that tranexamic acid might be an effective treatment for skin pigmentation disorders?
Research has shown that tranexamic acid can reduce skin discoloration by decreasing melanin, the substance that gives skin its color. Studies have found it effective in lightening dark patches in melasma, a condition similar to lichen planus pigmentosus (LPP) and erythema dyschromicum perstans (EDP). In treating melasma, it blocks the triggers that cause pigmentation. Although oral tranexamic acid is less effective than injections, it still shows promise for reducing skin discoloration. These findings suggest that tranexamic acid might also help with LPP and EDP similarly. Participants in this trial will take tranexamic acid tablets, 325mg twice daily for six months, to evaluate its effectiveness for skin pigmentation disorders.46789
Who Is on the Research Team?
Henry W Lim, MD
Principal Investigator
Henry Ford HS
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Lichen Planus Pigmentosus or Erythema Dyschromicum Perstans, who haven't used any treatments except sunscreen in the last month. It's not for those on blood thinners, hormone therapies recently, with a history of clots or severe kidney issues, active cancers (except skin cancer), migraines with aura, or women who are pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tranexamic acid tablets, 325mg twice daily for six months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tranexamic acid
Tranexamic acid is already approved in United States, European Union, Japan for the following indications:
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor