The study to evaluate the efficacy and safety of using Leukocyte poor Platelet-rich plasma for treating melasma in Thailand

Phase 4

• Conditions: Patient with melasma; Leukocyte poor Platelet-rich plasma, melasma

• Registration Number: TCTR20230201002
• Lead Sponsor: ASTRACO MEDICAL NETWORKS LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study Completion: 2023-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Aged 18-60 years
2.Asian
3.were diagnosed with melasma by dermatologist

Exclusion Criteria

1. Subjects who are pregnant
2.Subjects who had history of low platelet, coagulopathy or taking medicine of antocoagulant drug like warfarin
3.Subjects who has dermatits, wound or infection at treatment area
4.Subjects who allergy to anesthesia cream
5.Subjects who taken oral or injection contraceptive pills
6.Subjects who had history of melasma treatment within 6 months before arrived the project
7.Subjects who had history of laser at treatment area within 6 months before arrived the project
8.Subjects who had history of keloid or hypertrophic scar
9.Subjects who had history of psychitic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average melanin concentration Baseline,1 month after 1st treatment, 1 months after 2nd treatment and 2 week, 1,2,3,6 months after 3rd treatments Antera

Secondary Outcome Measures

Name	Time	Method
Melanin index Baseline,1 month after 1st treatment, 1 months after 2nd treatment and 2 week, 1,2,3,6 months after 3rd treatments mexameter,Erythema Index Baseline,1 month after 1st treatment, 1 months after 2nd treatment and 2 week, 1,2,3,6 months after 3rd treatments mexameter,safety Baseline,1 month after 1st treatment, 1 months after 2nd treatment and 2 week, 1,2,3,6 months after 3rd treatments adverse effect,Physician improvement scale Baseline,1 month after 1st treatment, 1 months after 2nd treatment and 2 week, 1,2,3,6 months after 3rd treatments Percent improvement,Patient improvement scale Baseline,1 month after 1st treatment, 1 months after 2nd treatment and 2 week, 1,2,3,6 months after 3rd treatments percent improvement,MASI Baseline,1 month after 1st treatment, 1 months after 2nd treatment and 2 week, 1,2,3,6 months after 3rd treatments MASI score