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The Clinical Efficacy of a Topical Tranexamic Acid Preparation in Improving Skin Hyperpigmentation

The Clinical Efficacy of a Topical Tranexamic Acid Preparation in Improving Skin Hyperpigmentation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107511
Enrollment
Unknown
Registered
2025-08-13
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Skin pigmentation

Interventions

Control:the base formula of the experimental group's product. It is identical to the experimental group's product in all aspects except for the absence of tranexamic acid, and has a similar appearance
experimental group:a topical tranexamic acid preparation

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: astaring@163.com, you can contact them 6 months after the end of the trial 1. Volunteer to participate in this trial, sign the informed consent form, agree to use the product and conduct testing; 2. Age within the range of 20-60 years old, male or female; 3. Meet the diagnostic criteria for post-inflammatory pigmentation and melasma, and adopt the expert consensus on the prevention and treatment of post-inflammatory pigmentation (2024 edition ) and the Chinese expert consensus on the diagnosis and treatment of melasma (2021 edition).

Exclusion criteria

Exclusion criteria: 1. Failure to fill in the informed consent form; 2. Pregnant or pregnant or lactating; 3. Those who have taken tranexamic acid or topical tranexamic acid in the past month; 4. Those who take oral contraceptives or hormone replacement therapy; 5. For those who are allergic to known ingredients of the product and patients with severe allergies; 6. Has a severe or progressive disease that, in the judgment of the investigator, presents an inappropriate risk for the subject to participate in this clinical trial (i.e., cancer or cancer symptoms, immunocompromised, uncontrolled diabetes, epilepsy, severe cardiovascular and cerebrovascular disease) 7. Those with other pigmented, immune and infectious skin diseases; 8. Other topical drugs and oral drugs with freckle removal and whitening effects have been used in the 2 weeks before and during the trial; 9. Other conditions that the investigator deems unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Melasma lesion area and severity index;Doctor's overall score;

Secondary

MeasureTime frame
Patient assessment;evaluation of product satisfaction;

Countries

China

Contacts

Public ContactLi Li

West China Hospital, Sichuan University

lily_hxyy@163.com+86 189 8060 1692

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026