MelasmaNCT07530016
Clinical Efficacy and Mechanisms of a Topical Azone-Tranexamic Acid-Aloe Polysaccharide Gel in the Treatment of Melasma
A study testing Ligustrazine - tranexamic acid - aloe polysaccharide composite gel in people with Melasma and Treatment of Stable Melasma, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Melasma, Treatment of Stable Melasma, Tranexamic Acid
- What is being tested?
- Ligustrazine - tranexamic acid - aloe polysaccharide composite gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2026to 16 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-50 years diagnosed with melasma Famale
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Melasma, Treatment of Stable Melasma, Tranexamic Acid, Laurocapram
- Being tested
- Ligustrazine - tranexamic acid - aloe polysaccharide composite gel
- Keywords
- Improve transdermal efficiency, Treatment of stable melasma
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligustrazine - tranexamic acid - aloe polysaccharide composite gelCombination product
Clinical efficacy and mechanism study of laurel nitrate - tranexamic acid - aloe polysaccharide composite gel in the treatment of chloasma
| Study group | Role | What they receive |
|---|---|---|
| Ligustrazine - tranexamic acid - aloe polysaccharide composite gel | Experimental | Not described Receives: Combination Product: Ligustrazine - tranexamic acid - aloe polysaccharide composite gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start12 Aug 2026 (estimated)
- Primary completion25 Dec 2027 (estimated)
- Study completion16 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530016
- Sponsor's protocol ID
- LDTAAPC-2026
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07530016
- Acronym / sponsor ID
- LDTAAPC-2026
- Conditions
- Melasma, Treatment of Stable Melasma, Tranexamic Acid, Laurocapram
- Keywords
- Improve transdermal efficiency, Treatment of stable melasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 12 Aug 2026 (estimated)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 16 Nov 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ligustrazine - tranexamic acid - aloe polysaccharide composite gel | Experimental | Combination Product: Ligustrazine - tranexamic acid - aloe polysaccharide composite gel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients aged 18-50 years diagnosed with melasma Famale
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligustrazine - tranexamic acid - aloe polysaccharide composite gelClinical efficacy and mechanism study of laurel nitrate - tranexamic acid - aloe polysaccharide composite gel in the treatment of chloasma | Combination product | Ligustrazine - tranexamic acid - aloe polysaccharide composite gel |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ligustrazine - tranexamic acid - aloe polysaccharide composite gel in people with Melasma and Treatment of Stable Melasma, run by The First Affiliated Hospital of Xinxiang Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjie Ren (8613937354075, 13937354075@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total participants are 10 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.