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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligustrazine - tranexamic acid - aloe polysaccharide composite gel | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total participants are 10 | 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. | 12 weeks |
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Inclusion Criteria:
Adult patients aged 18-50 years diagnosed with melasma Famale
Exclusion Criteria:
Patients with a history of hypersensitivity to any of the medications. Patients already taking treatment of melasma
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjie Ren | Contact | 8613937354075 | 13937354075@163.com |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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