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

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07530016
Enrollment
10
Registered
2026-04-14
Start date
2026-08-12
Completion date
2028-11-16
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laurocapram, Melasma, Tranexamic Acid, Treatment of Stable Melasma

Keywords

Improve transdermal efficiency, Treatment of stable melasma

Brief summary

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.

Detailed description

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.

Interventions

COMBINATION_PRODUCTLigustrazine - tranexamic acid - aloe polysaccharide composite gel

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

Sponsors

The First Affiliated Hospital of Xinxiang Medical College
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total participants are 1012 weeksTen 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.

Contacts

CONTACTWenjie Ren
13937354075@163.com8613937354075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026