Topical Tranexamic Acid Does Not Produce Notable Benefits in Macular Amyloidosis

Microneedling alone proved efficacious in improving pigmentation and decreasing pruritus in patients with macular amyloidosis, though the addition of topical tranexamic acid did not produce any notable clinical benefits, according to a study published in the Journal of Cosmetic Dermatology.¹

Despite this, researchers reported no significant differences in levels of patient satisfaction with monotherapy versus combination therapy.

Image Credit: DermNet

Background and Methods

Randomized controlled trial data published in Dermatologic Therapy reported that while both intralesional injection of tranexamic acid and topical application of a Kligman combination drug yielded benefits, intralesional injection more significantly reduced melanin content of affected lesions.² Authors of the study noted that tranexamic acid be used in combination with other therapeutic modalities in further research.

Authors of the present study, Gheisari et al, also noted the limited quantity of scientific literature exploring the use of tranexamic acid in cases of macular amyloidosis. In order to address this unmet need, they conducted a randomized controlled trial between March 2021 and 2022 in an effort to compare the use of topical tranexamic acid alone versus tranexamic acid used in combination with microneedling.

Patients enrolled in the study (n=20) were females aged 18 years of age and older with a diagnosis of bilateral macular amyloidosis. Medical history inclusive of autoimmune disorders, tendency to develop keloids, and active treatment for macular amyloidosis, were grounds for exclusion. Photographs were collected at baseline, and patients were instructed to halt application of any topical medications while also limiting ultraviolet exposure.

Researchers split skin lesions into a left side and right side, with 1 side set to receive tranexamic acid as a monotherapy and the other to receive treatment with both microneedling followed by the application of tranexamic acid. Treatment took place on a biweekly basis for a total of 4 treatments per participant. In order to achieve clinical trial blinding, researchers first applied an anesthetic cream; after microneedling, the monotherapy side was coated in a saline solution.

Findings

Following all 4 treatment sessions, researchers reported that there was not any significant or marked differences in pigmentation change achieved when comparing the 2 treatments.

However, among the 68.4% of total patients presenting with pruritus as a dominant symptom, 61.66% reported improvements following treatment.

Researchers also reported that length of disease duration also correlated with improvements achieved, noting that individuals with a greater duration of disease achieved more significant improvements as a result of treatment. Improvement in the rippling patterns of lesions also correlated with lengthier disease duration.

The majority of patients (70%) did not report adverse effects. Any reported effects, such as bruise, burning sensation, or acne, were generally mild and transient in nature.

Patients were also similarly satisfied when comparing both treatments. Forty-six point five percent reported satisfaction with tranexamic acid application alone, while 47.5% reported satisfaction with the combined treatment approach.

Conclusions

"To the best of our knowledge, our study is the first study on evaluation of the effect of topical tranexamic acid with micro-needling and comparison of this method with micro-needling alone on macular amyloidosis lesions," according to Gheisari et al. "The results of our study showed no difference between both groups (with and without tranexamic acid) regarding the pigmentation improvement (based on photographs and dermoscopy), changing rippling pattern, and patient satisfaction."

The study may have been limited, however, by an absence of macular amyloidosis biopsy and existing data.

Future studies should consider assessing the use of therapies via biopsy, according to authors. This may aid in the assessment of reduction in amyloid deposits and melanophages in the skin. As microneedling proved efficacious in this condition, researchers also posed the suggestion that clinical trials explore its use in similarly chronic conditions, such as lichen simplex chronicus.

References

1. Gheisari M, Ghalamkarpour F, Haghighi SM, et al. The effect of topical tranexamic acid with micro-needling and micro-needling alone in treatment of macular amyloidosis. J Cosmet Dermatol. August 6, 2024. https://doi.org/10.1111/jocd.16517
2. Ghassemi M, Roohaninasab M, Kamani SA, Sadeghzadeh-Bazargan A, Goodarzi A. Comparison of the efficacy and safety of intralesional injection of tranexamic acid and the topical application of Kligman combination drug in the treatment of macular amyloidosis. Dermatol Ther. 2022;35(1):e15213. doi:10.1111/dth.15213