Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris

Overseen By Steven D Daveluy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Wayne State University

Must not be taking: Hydroquinone, Kojic acid, others

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

This trial is testing a skin cream called topical tranexamic acid to see if it can lighten dark spots from acne. It is aimed at people who can't use the usual treatment because of side effects. The cream works by reducing skin pigment and has few reported side effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used certain skin treatments like hydroquinone, kojic acid, tretinoin, adapalene, tazarotene, or azaleic acid in the past 3 months.

What data supports the effectiveness of the drug Tranexamic Acid (TXA)?

Research shows that Tranexamic Acid (TXA) is effective in reducing blood loss and the need for blood transfusions during total knee replacement surgery and in reducing bleeding deaths after injury and childbirth. It has been widely used in trauma care with positive outcomes, including reduced mortality without increasing adverse events. ^{1 2 3 4 5}

Is Tranexamic Acid (TXA) generally safe for humans?

Tranexamic Acid (TXA) is generally considered safe for humans, as studies have shown it reduces bleeding and mortality in trauma and surgery patients without significant safety concerns. However, there is some concern about the risk of thrombotic complications (blood clots), so it should be used with caution in people at risk for these issues. ^{6 7 8 9 10}

How does the drug tranexamic acid differ from other treatments for reducing blood loss in knee surgery?

Tranexamic acid is unique because it helps reduce blood loss during knee surgery by preventing the breakdown of blood clots, which can decrease the need for blood transfusions. Unlike some other treatments, it is effective with just a single dose and does not significantly increase the risk of blood clots or other major adverse events. ^{1 11 12 13 14}

Research Team

Steven Daveluy

Principal Investigator

WSUPG Dermatology

Eligibility Criteria

Inclusion Criteria

Patients with bilateral involvement of facial postinflammatory hyperpigmentation due to acne vulgaris.

Age 18 to 65

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply topical tranexamic acid to the dark spots on one side of their face and a vehicle cream on the other side for 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in pigmentation using the postacne hyperpigmentation index

4 weeks

Treatment Details

Interventions

• Tranexamic Acid
• Vehicle

Participant Groups

Group I: Right Side of Face Experimental Treatment 1 Intervention

Patients will apply topical tranexamic acid to the dark spots on the one side of their face.

Group II: Left Side of Face Placebo Group 1 Intervention

Patients will apply the vehicle cream without any medication to the dark spots on one side of their face.

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Findings from Research

A meta-analysis of 28 randomized controlled trials involving 4,200 participants found that combined administration of tranexamic acid (TXA) significantly reduces total blood loss and postoperative hemoglobin drop compared to using TXA through a single route (oral, intravenous, or topical).

Oral administration of TXA showed similar efficacy to intravenous or topical routes, indicating that it can be an effective alternative for reducing blood loss in total knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the ideal route of administration of tranexamic acid in total knee arthroplasty? A meta-analysis based on randomized controlled trials. Lu, F., Sun, X., Wang, W., et al.[2021]

In a study of 60 patients undergoing bilateral total knee arthroplasty, intravenous tranexamic acid (TXA) significantly reduced total blood loss and the need for blood transfusions compared to the control group, indicating its efficacy in managing perioperative blood loss.

The use of TXA did not increase the risk of deep vein thrombosis or other thromboembolic events, suggesting it is a safe option for patients undergoing knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A PROSPECTIVE RANDOMIZED SELF-CONTROLLED STUDY ON EFFECT OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS IN TOTAL KNEE ARTHROPLASTY]. Huang, Z., Zhang, W., Li, W., et al.[2018]

In a study of 273 adult trauma patients receiving tranexamic acid (TXA) at a U.S. Level I trauma center, the overall mortality rate within 28 days was 12.8%, which is comparable to the 14.5% mortality rate observed in the CRASH-2 trial, indicating that TXA is effective in reducing mortality in traumatic hemorrhage.

However, the incidence of acute thromboembolic events was higher in this cohort at 6.6%, compared to 2.0% in the CRASH-2 trial, suggesting that while TXA is beneficial, it may also carry a higher risk of thromboembolic complications in certain patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality and Complication Rates in Adult Trauma Patients Receiving Tranexamic Acid: A Single-center Experience in the Post-CRASH-2 Era. Erramouspe, PJ., García-Pintos, MF., Benipal, S., et al.[2020]

In a study of 164 patients undergoing total hip replacement, a single injection of 30 mg/kg tranexamic acid (TXA) was found to be as effective as a continuous infusion in reducing blood loss, with no significant difference in mean blood loss between the two methods.

Both treatment methods were safe, with no reported deaths or major thromboembolic events within 90 days post-surgery, suggesting that the single injection is a practical and effective option for routine use in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single tranexamic acid dose to reduce perioperative morbidity in primary total hip replacement: a randomised clinical trial. Hourlier, H., Fennema, P.[2023]

Tranexamic acid (TxA) significantly reduces the volume of hematomas after total knee arthroplasty (TKA), with a decrease from 526 mL in the control group to 337 mL in the TxA group, indicating its efficacy in minimizing blood loss.

Despite the reduction in hematoma volume, TxA did not lead to a significant decrease in morphine consumption for pain management or improve rehabilitation outcomes within the first six months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tranexamic acid reduces haematomas but not pain after total knee arthroplasty]. Chevet, I., Remérand, F., Couvret, C., et al.[2013]

References

1. China pubmed.ncbi.nlm.nih.gov

What is the ideal route of administration of tranexamic acid in total knee arthroplasty? A meta-analysis based on randomized controlled trials. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of intramuscular tranexamic acid in bleeding trauma patients: a clinical trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Mortality and Thrombosis in Injured Adults Receiving Tranexamic Acid in the Post-CRASH-2 Era. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of age on the efficacy of tranexamic acid: An analysis of heterogeneity of treatment effect within the CRASH-2 dataset. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[A PROSPECTIVE RANDOMIZED SELF-CONTROLLED STUDY ON EFFECT OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS IN TOTAL KNEE ARTHROPLASTY]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral tranexamic acid in total knee arthroplasty: A systematic review and meta-analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Mortality and Complication Rates in Adult Trauma Patients Receiving Tranexamic Acid: A Single-center Experience in the Post-CRASH-2 Era. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Role of Tranexamic Acid in the Clinical Setting. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Single tranexamic acid dose to reduce perioperative morbidity in primary total hip replacement: a randomised clinical trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

One dose of tranexamic acid is safe and effective in revision knee arthroplasty. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Tranexamic acid mediates proinflammatory and anti-inflammatory signaling via complement C5a regulation in a plasminogen activator-dependent manner. [2020]

13. France pubmed.ncbi.nlm.nih.gov

[Tranexamic acid reduces haematomas but not pain after total knee arthroplasty]. [2013]

14. England pubmed.ncbi.nlm.nih.gov

The incidence of venous thromboembolic events in trauma patients after tranexamic acid administration: an EAST multicenter study. [2021]