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Efficacy Study of Intradermal Injection of Tranexamic Acid at Different Concentrations for the Treatment of Melasma and Post-Inflammatory Hyperpigmentation After Phototherapy

Efficacy Study of Intradermal Injection of Tranexamic Acid at Different Concentrations for the Treatment of Melasma and Post-Inflammatory Hyperpigmentation After Phototherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109099
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-06-18
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Melasa and Post-inflammatory hyperpigmentation after phototherapy

Interventions

Melasma 4mg/ml group:A trace intradermal injection of 4mg/ml tranexamic acid was given to the lesion area on half of the face. Once every two weeks for a total of four sessions
Melasma 50mg/ml group:A trace intradermal injection of 50mg/ml tranexamic acid was given to the lesion area on half of the face. Once every two weeks for a total of four sessions
PIH 4mg/ml group:A trace intradermal injection of 4mg/ml tranexamic acid was given to the lesion area on half of the face. Once every two weeks for a total of four sessions
PIH 50mg/ml group:A trace intradermal injection of 50mg/ml tranexamic acid was given to the lesion area on half of the face. Once every two weeks for a total of four sessions

Sponsors

Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the melasma group: 1. Adult patients aged 25–60 years with bilaterally symmetrical melasma. 2. Patients willing to receive intradermal tranexamic acid injections for facial melasma improvement and who voluntarily provide written informed consent. 3. Not concurrently participating in any other clinical trial. Inclusion criteria for the PIH group: 1. Adult patients aged 25–60 years with at least one lesion of post-inflammatory hyperpigmentation (PIH) on each side of the face, resulting from prior light- or energy-based treatments, and with PIH duration exceeding 3 months. 2. Patients willing to receive intradermal tranexamic acid injections for facial PIH improvement and who voluntarily provide written informed consent. 3. Not concurrently participating in any other clinical trial.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the melasma group: 1. Allergy to tranexamic acid or presence of contraindications to its use. 2. Severe infection, skin lesions, or scarring in the treatment area, rendering local injection unsuitable. 3. Coexisting severe systemic diseases, such as endocrine disorders, skin tumors, or immune/coagulation dysfunction. 4. History of laser therapy, chemical peeling, or use of pigment-inhibiting agents (topical or oral) in the melasma-affected area within the past 3 months. 5. Pregnant or lactating women. Exclusion criteria for the PIH group: 1. Allergy to tranexamic acid or presence of contraindications to its use. 2. Severe infection, skin lesions, or scarring in the treatment area, rendering local injection unsuitable. 3. Coexisting severe systemic diseases, such as endocrine disorders, skin tumors, or immune/coagulation dysfunction. 4. Use of hydroquinone, retinoid analogs, or other depigmenting agents within 4 weeks prior to enrollment; or any procedural treatments (e.g., laser therapy, chemical peels) performed within the past 6 months. 5. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
hemi-melasma area and severity index;Individual type Angle;Light Index;

Secondary

MeasureTime frame
Clinical efficacy;Patient satisfaction;

Countries

China

Contacts

Public ContactHuang Lvping

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

lphuang2003@163.com+86 177 2127 1572

Outcome results

None listed

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