Study Summary
This trial seeks to determine whether tranexamic acid can reduce pigmentation in patients with LPP and EDP.
Eligible Conditions
- Lichen Planus Pigmentosus
- Fitzpatrick's Skin Type IV
- Ashy Dermatosis of Ramirez
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: 11 visits over 270 days
Day 270
Change in Erythema using Colorimetry
Change in Erythema using Diffuse Reflectance Spectroscopy
Change in Pigmentation using Colorimetry
Change in Pigmentation using Diffuse Reflectance Spectroscopy
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
3900 mg/Day
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%Tachycardia
1%Decreased Blood Sugar
Trial Design
1 Treatment Group
Treatment
1 of 1
Experimental Treatment
5 Total Participants · 1 Treatment Group
Primary Treatment: Tranexamic acid tablets · No Placebo Group · Phase 2
Treatment
Drug
Experimental Group · 1 Intervention: Tranexamic acid tablets · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 11 visits over 270 days
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
265 Previous Clinical Trials
2,014,437 Total Patients Enrolled
Henry W Lim, MDPrincipal InvestigatorHenry Ford HS
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Bala, Harini R., Senhong Lee, Celestine Wong, Amit.G. Pandya, and Michelle Rodrigues. 2018. “Oral Tranexamic Acid for the Treatment of Melasma: A Review”. Dermatologic Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/dss.0000000000001518.
- Molinar, Vanessa E., Susan C. Taylor, and Amit G. Pandya. 2014. “What’s New in Objective Assessment and Treatment of Facial Hyperpigmentation?”. Dermatologic Clinics. Elsevier BV. doi:10.1016/j.det.2013.12.008.
- Kim, S. J., J.-Y. Park, T. Shibata, R. Fujiwara, and H. Y. Kang. 2016. “Efficacy and Possible Mechanisms of Topical Tranexamic Acid in Melasma”. Clinical and Experimental Dermatology. Wiley. doi:10.1111/ced.12835.
- Lee, Hwee Chyen, Tien Guan Steven Thng, and Chee Leok Goh. 2016. “Oral Tranexamic Acid (TA) in the Treatment of Melasma: A Retrospective Analysis”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2016.03.001.
- Kanwar, A. J., S. Dogra, S. Handa, D. Parsad, and B. D. Radotra. 2003. “A Study of 124 Indian Patients with Lichen Planus Pigmentosus”. Clinical and Experimental Dermatology. Wiley. doi:10.1046/j.1365-2230.2003.01367.x.
- Coondoo, Arijit, and Aparajita Ghosh. 2016. “Lichen Planus Pigmentosus: The Controversial Consensus”. Indian Journal of Dermatology. Medknow. doi:10.4103/0019-5154.190108.
- 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.
- 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.
- 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.
- 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.
- Henry W. Lim 2020. "The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04233749.
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