Clinical Efficacy and Mechanisms of a Topical Azone-Tranexamic Acid-Aloe Polysaccharide Gel in the Treatment of Melasma

Melasma is a common pigmentation disorder among young and middle-aged women, characterized by symmetrical brown-black patches on the face. It is related to genetics, ultraviolet radiation, endocrine factors and inflammation, and can lead to psychological problems and affect quality of life. Current treatments such as hydroquinone stimulation, laser therapy, and oral tranexamic acid have a high recurrence rate and poor compliance. The new gel formulation, which combines tranexamic acid (to inhibit tyrosinase), aloe polysaccharides (anti-inflammatory and repair), and lauric azon (promotes penetration), is expected to enhance efficacy and reduce side effects. This study aims to explore its clinical efficacy and synergistic mechanism, providing new strategies for the treatment of Melasma.

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Key information

Conditions

Melasma Hyperpigmentation Laurocapram Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Tranexamic Acid Treatment of Stable Melasma

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Based on the clear clinical needs and scientific questions specified in the research background, and in combination with the core characteristics of the composite gel, the following research objectives are proposed, focusing on efficacy verification, mechanism elucidation, and exploration of application value: (1) To clarify the clinical efficacy of the lauric acid ketone - tranexamic acid - aloe polysaccharide composite gel in the treatment of melasma. Through objective quantitative indicators (such as melasma area and severity index, pigmentation score) to evaluate its improvement effect on the patch area and color depth, and at the same time observe the incidence of adverse reactions such as skin irritation, to verify the safety of the formulation. (2) To preliminarily clarify the synergistic mechanism of this composite gel in the treatment of melasma, focusing on exploring its influence on the key enzyme of melanin synthesis (tyrosinase) activity, as well as its regulatory effect on skin inflammatory factors (IL-6, TNF-α) and antioxidant indicators (SOD, MDA), and revealing the molecular basis of the synergistic action of the three. (3) To provide experimental basis for the clinical transformation and application of the lauric acid ketone - tranexamic acid - aloe polysaccharide composite gel, optimize the clinical usage scheme of the topical formulation, and provide a safer and more efficient new treatment option for patients with melasma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients aged 18-50 years diagnosed with melasma Famale

Exclusion criteria

Patients with contraindications to melatonin, including pregnancy, breastfeeding, autoimmune disorders, bleeding disorders, and diabetes, or contraindications to tranexamic acid, including thromboembolic events, history of thrombosis, renal impairment, and pregnancy or breastfeeding.

Patients with a history of hypersensitivity to any of the medications. Patients already taking treatment of melasma

Treatment and study plan

Ligustrazine - tranexamic acid - aloe polysaccharide composite gel

Combination Product

Clinical efficacy and mechanism study of laurel nitrate - tranexamic acid - aloe polysaccharide composite gel in the treatment of chloasma

Primary outcomes

Total participants are 10

Time frame: 12 weeks

Ten patients applied the composite hydrogel for 12 weeks. The MASI score was calculated at the 1st, 6th, and 12th weeks respectively to assess the improvement. A score lower than 10 was classified as mild, 11-20 as moderate, and over 20 as severe melasma. A 25% improvement in the MASI score would be considered the threshold for effective treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjie Ren

CONTACT

[email protected]

8613937354075

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xinxiang Medical College

Other

Registry information

Official study title

Melasma is a Common Pigmented Skin Disease, Related to Genetics and Ultraviolet Rays, and Prone to Causing Psychological Problems. The Current Treatments Have Limitations. The Combination Gel of Tranexamic Acid, Aloe Polysaccharide and Lauric Azonide is Expected to Enhance Efficacy and Reduce Side Effects. This Study Explores Its Therapeutic Effect and Mechanism, Providing New Strategies.

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Apr 14, 2026
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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