Topical Tranexamic Acid for Hyperpigmentation from Acne

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream with 5% tranexamic acid (also known as TXA, Cyklokapron, or Lysteda) to determine its effectiveness in lightening dark spots left by acne, known as postinflammatory hyperpigmentation. Many individuals cannot tolerate the usual treatments, but this cream may offer easier use with fewer side effects. Participants will apply the cream to dark spots on one side of their face, while the other side receives a cream without the active ingredient for comparison. Those with dark spots from acne on both sides of their face who have not used certain skin products in the last three months may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to potential new solutions for acne-related hyperpigmentation.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that topical tranexamic acid is generally safe and well-tolerated. Studies on its use for skin conditions like melasma indicate that it rarely causes serious side effects. Some individuals might experience mild skin issues such as redness, irritation, or dryness at the application site. These effects are typically not serious and usually resolve on their own. Participants in the trial should monitor their skin's reaction and report any concerns to the study team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for postinflammatory hyperpigmentation from acne, which often involve topical lightening agents like hydroquinone or retinoids, tranexamic acid offers a fresh approach. Tranexamic acid is unique because it works by inhibiting melanin synthesis, potentially reducing pigmentation more effectively. Researchers are excited about its potential to provide a targeted treatment that minimizes dark spots without the irritation sometimes associated with other depigmenting agents. Also, being applied topically, it offers a convenient and non-invasive option for patients.

What evidence suggests that tranexamic acid might be an effective treatment for dark spots from acne?

Research has shown that a 5% tranexamic acid cream can help treat skin discoloration. It speeds up the healing of darkened skin caused by damage or conditions like melasma, similar to dark spots left by acne. Unlike hydroquinone, a common treatment that some find hard to tolerate, tranexamic acid is easier to use and has fewer side effects. In this trial, participants will apply topical tranexamic acid to the dark spots on one side of their face, while the other side will receive a vehicle cream without medication. Studies have found that both oral and topical tranexamic acid can reduce dark spots, suggesting it could be a good option for those dealing with acne-related dark spots. ^{4 6 7 8 9}

Who Is on the Research Team?

Steven Daveluy

Principal Investigator

WSUPG Dermatology

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Age 18 to 65

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid
• Vehicle

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11439988/

Tranexamic Acid for the Treatment of Hyperpigmentation ... It has been found that the topical administration of 5% tranexamic acid considerably hastens the regeneration of physicochemical-damaged skin ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S209669112400061X

Different administration routes of tranexamic acid in the ... Overall, topical TXA is an effective and safe treatment for melasma and is more tolerable with fewer side effects than the traditional topical hydroquinone ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03361345

Topical 5% Tranexamic Acid as a Treatment for ... Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 4 weeks. The postacne hyperpigmentation index (PAHPI) ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.70428?af=R

Randomized Clinical Trial on the Efficacy of Oral ... In this study, oral and topical TXA showed similar effectiveness in reducing melasma severity over a 12-week period, with minimal adverse ...

5. mdpi.com mdpi.com/2079-9284/11/5/168

Pilot Clinical Safety and Efficacy Evaluation of a Topical 3 ... Subjective assessments reflected high user satisfaction, with 95% of participants noting improvements in skin hydration and luminosity, and 77% reporting a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10412040/

Efficacy and Safety of Topical Tranexamic Acid Alone or in ... Topical TXA is a safe and fairly effective treatment modality for facial melasma. Combining TXA with either fractional CO2 laser or MN yielded significantly ...

7. dermnetnz.org dermnetnz.org/topics/tranexamic-acid

Tranexamic acid Tranexamic acid is mostly well-tolerated. In the most extensive case series of patients treated with tranexamic acid for melasma for a median duration of 4 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03585179

Oral and Topical Tranexamic Acid for the Treatment ... This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks ...

9. go.drugbank.com go.drugbank.com/drugs/DB00302

Tranexamic acid: Uses, Interactions, Mechanism of Action Tranexamic acid is an antifibrinolytic used to reduce or prevent hemorrhagic episodes, especially in the context of hyperfibrinolytic disorders.