Chloasma
Conditions
Interventions
Group A: Facial collagen tightening treatment with the introduction of tranexamic acid solution (tranexamic acid essence):I will use the 20mm anti-aging all-in-one gun (pressure 1.0 - 1.5 bar, frequen
using a 2.5 ml syringe to draw the tranexamic acid solution (5 ml : 0.5 g), drip it onto the face, and apply the 26mm collagen gun (pressure 1.0 - 1.5 bar, frequency 10 - 15 Hz) for local 1000 - 3000
Group B: Apply amicarfen solution (amicarfen essence) externally to the face.:Using a 2.5 ml syringe, draw out tranexamic acid (5 ml : 0.5 g), apply it to the face, and perform self-massage. This proc
Sponsors
Shenzhen People’s Hospital (The First Affiliated Hospital, Southern University of Science and Technology;The Second Clinical Medical College,Jinan University)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Comply with the Chinese Expert Consensus on the Diagnosis and Treatment of Melasma (2021 Edition) for melasma diagnosis; 2. Age between 18 and 65 years old; 3. Female patients; 4. The patient has a clear consciousness, signs the consent form by himself, and is willing to provide medical history and accept follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; 2. Taking anticoagulants, contraceptives, sex hormones, thyroxine and other drugs, which may affect the evaluation of efficacy; 3. Pigmentation caused by facial skin diseases and other diseases; 4. Coagulation dysfunction; Those with severe liver, kidney, cardiovascular, respiratory, hematopoietic, immune and other system diseases, malignant tumors and mental diseases; 5. Patients with neurogenic tinnitus (or severe tinnitus), vertigo, periodontitis, etc. who are not suitable for cold lifting treatment; 6. Received other treatments (drugs, lasers, intense pulsed light, chemical peels, etc.) within 6 months; 7. Those with high treatment expectations. 8. Those who are allergic to the ingredients of this drug; 9. Other general conditions that make them unsuitable for participation in the study: Participation in any other clinical trial within 3 months prior to screening; those who cannot tolerate pain; Those who have a history of drug abuse within 6 months before screening or have used drugs within 3 months before screening; Infectious diseases before screening, such as syphilis, AIDS, hepatitis B, etc.; Subjects who are pregnant or lactating; Subjects with severe cardiovascular, gastrointestinal, respiratory, endocrine, nephritis, hepatic disease or hepatic insufficiency, history of malignant tumors (diagnosed with malignant tumors in the past 5 years) or central nervous system disorders, and mental disorders that may adversely affect this clinical trial; Presence of any other comorbid disease that, in the opinion of the investigator alone, may interfere with the evaluation of the study, or that participation in the study may expose the subject to greater risk; Subjects who are considered unsuitable for participation in this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MASI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| VISIA and 3D digital plastic surgery scanning instrument image analysis quantifies pigments and blood vessels at different levels.;Dermoscopy: To evaluate the improvement of the number and morphology of blood vessels in the lesion area before and after the treatment of chloasma.;Skin ultrasound examination: 1) Photoacoustic imaging. Observe the changes in oxygen content before and after the treatment.;Skin ultrasound examination: 2) Viscoelastic imaging. Analyze the changes in viscoelasticity before and after treatment.;Skin ultrasound examination: 3) Ultrasound microvascular imaging. Quantitative detection of blood flow changes before and after treatment was conducted.; | — |
Countries
China
Contacts
Public ContactJianglin Zhang
Shenzhen People’s Hospital (The First Affiliated Hospital, Southern University of Science and Technology;The Second Clinical Medical College,Jinan University)
Outcome results
None listed