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Anti-fibrinolytic agent

Tranexamic Acid for Skin Pigmentation Disorders

Phase 2
Recruiting
Led By Henry W Lim, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject with a diagnosis of LPP, EDP, or AD
Subject age 18 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 visits over 270 days
Awards & highlights

Study Summary

This trial seeks to determine whether tranexamic acid can reduce pigmentation in patients with LPP and EDP.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if Tranexamic acid tablets can help reduce skin pigmentation in conditions like LPP and EDP by possibly affecting plasmin levels which are involved in pigmentation. There's no current effective treatment for these conditions.See study design
What are the potential side effects?
Tranexamic acid may cause side effects such as nausea, diarrhea, stomach pain; less commonly it could increase clotting risks leading to serious events like deep vein thrombosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with LPP, EDP, or AD.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 visits over 270 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 visits over 270 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pigmentation using Colorimetry
Change in Pigmentation using Diffuse Reflectance Spectroscopy
Secondary outcome measures
Change in Erythema using Colorimetry
Change in Erythema using Diffuse Reflectance Spectroscopy

Side effects data

From 2008 Phase 3 trial • 196 Patients • NCT00386308
59%
Headache
37%
Nasal & Sinus Symptoms
24%
Back Pain
20%
Abdominal Pain
11%
Musculoskeletal Pain
10%
Anemia
9%
Arthralgia
8%
Muscle Cramps & Spasms
7%
Fatigue
6%
Migraine
1%
Decreased Blood Sugar
1%
Tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
3900 mg/Day
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All five subjects will receive tranexamic acid tablets, 325mg twice daily for six months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid tablets
2006
Completed Phase 3
~590

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,994 Total Patients Enrolled
Henry W Lim, MDPrincipal InvestigatorHenry Ford HS

Media Library

Tranexamic acid (Anti-fibrinolytic agent) Clinical Trial Eligibility Overview. Trial Name: NCT04233749 — Phase 2
Lichen Planus Pigmentosus Research Study Groups: Treatment
Lichen Planus Pigmentosus Clinical Trial 2023: Tranexamic acid Highlights & Side Effects. Trial Name: NCT04233749 — Phase 2
Tranexamic acid (Anti-fibrinolytic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04233749 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions does Tranexamic acid tablets typically address?

"Tranexamic acid tablets can be applied to treat hyperfibrinolysis, hemophilia, and bleeding."

Answered by AI

Is the enrollment process for this experiment still open?

"Affirmative, clinicaltrials.gov verifies that this research is presently recruiting participants. It was initially advertised on March 17th 2020 and recently modified on February 7th 2022. The investigation requires 5 volunteers from a single location."

Answered by AI

Has the FDA given its stamp of approval to Tranexamic acid tablets?

"Tranexamic acid tablets have preliminary evidence of safety, so it earned a rating of 2. However, since this is only Phase 2 trial, there isn't any empirical data to support its efficacy."

Answered by AI

What is the quota for participants in this medical investigation?

"Indeed, the data listed on clinicaltrials.gov indicates that this examination is actively enrolling individuals. It was originally posted online March 17th 2020 and last edited February 7th 2022. The research needs to acquire 5 patients from only one medical facility."

Answered by AI

Could you provide a summary of prior investigations involving Tranexamic acid tablets?

"At the present moment, 61 clinical trials for Tranexamic acid tablets are underway. Of those studies, 26 have progressed to Phase 3. Kaohsiung City, Yanchao District houses the bulk of these investigations; however 185 sites across the globe are also running studies related to this treatment."

Answered by AI
~1 spots leftby Apr 2025