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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorThe First Affiliated Hospital of Xinxiang Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Ligustrazine - tranexamic acid - aloe polysaccharide composite gelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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