gold radiofrequency microneedling procedure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged eighteen to sixty years old (inclusive), regardless of gender; 2. Subjects receiving gold radiofrequency microneedling on the face; 3. Willing to complete all study procedures as required; 4. Voluntarily participate in this clinical trial and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Development of severe adverse reactions after facial gold radiofrequency microneedling requiring systemic treatment or significantly interfering with daily life, including infection, thermal burns, and severe breakout of acneiform rashes; 2. Known allergy to sodium hyaluronate, silk fibroin, or recombinant collagen components; 3. Systemic infectious skin diseases; 4. Photosensitivity or keloid-prone constitution; 5. Presence of any severe underlying diseases, such as severe cardiac, cerebral, hepatic, renal, pulmonary, hematological and other systemic diseases, as well as systemic muscular movement disorders; 6. Severe psychiatric disorders accompanied by poor self-control and inability to express thoughts clearly; 7. Female subjects during pregnancy or lactation; 8. Participation in other interventional clinical trials within one month before screening; 9. Any other conditions judged by the investigator to render the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing Rate of Adverse Reactions Following Gold Radiofrequency Microneedling; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjects' satisfaction with the study product;Healing rates of adverse reactions at Day 3 and Day 7 post-procedure;Adverse Event;Overall healing time and the healing time of each adverse reaction;Changes in skin physiological function at Day 3, Day 7 and Day 14 post-procedure relative to baseline;Changes in skin imaging features at Day 3, Day 7 and Day 14 post-procedure relative to immediate post-procedure (D0); | — |
Countries
China
Contacts
Guangzhou Eighth Peoples Hospital Guangzhou Medical University