Therapeutic efficiency and safety assessment of intradermal platelet rich plasma combined with oral tranexamic acid in patients with facial melasma

Phase 2

• Conditions: Facial melasma; Melasma

• Registration Number: TCTR20230317003
• Lead Sponsor: WU grant, Walailak university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-17
• Study Completion: 2024-02-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 18-60 years
2. Diagnosed with facial melasma by dermatologists

Exclusion Criteria

1. Not willing to participate to the study
2. Allergic to lidocaine, prilocaine, tranexamic acid, chlorhexidine or isopropyl alcohol
3. Allergic to blood components
4. Currently treated with other modalities of melasma (or within 6 months)
5. Pregnancy or lactation
6. History of hematologic disorders
7. History of neurologic disorders
8. History of cancer
9. Hormonal therapy
10. Smoking/alcohol drinking
11. Abnormal liver function test (alanine aminotransferase > 5 times upper normal limits)
12. Abnormal creatinine (serum creatinine > 3.5 mg/dL)
13. Methemoglobinemia
14. Sepsis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Melasma Area Severity Index (mMASI) 12 weeks Scores

Secondary Outcome Measures

Name	Time	Method
Physician's Global Assessment (PGA) 12 weeks Scores,Patient satisfcation 12 weeks Scores,Melasma Quality of Life scale (MELASQOL) 12 weeks Scores