Facial Wrinkling
Conditions
Interventions
Test group:Profound
Control group:EndyMed
Sponsors
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged >=20 years old, no gender restrictions; 2. Fitzpatrick skin types II to IV; 3. Facial Fitzpatrick wrinkle and elasticity score > 3 points; 4. Good health, no abnormality in blood routine examination and coagulation function test; 5. Voluntarily receive treatment and cooperate with follow-up; 6. Voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received radiofrequency treatment in the past 1 year or have injected botulinum toxin or implanted devices, silicone, fat, collagen, synthetic materials or any medical objects in the area to be treated; 2. Have used tretinoin and isotretinoin in the past 1 year; 3. Those who have received facial laser skin resurfacing and deep chemical peeling in the past 6 months; 4. Have experienced any facial cosmetic surgery in the past 3 years; 5. Judgment of the impact of related skin care has been done within the past 1 month; 6. Have a history of severe skin allergies; 7. Subjects with a history of thermal irritation (eg, recurrent herpes simplex at the treatment site) should be treated only after a prophylactic regimen; 8. Any disease at the treatment site, such as multiple dysplastic moles, pain, psoriasis, eczema and rash; 9. History of skin diseases, keloids, abnormal wound healing, and sensitive dry skin or scar constitution; 10. Hypersensitivity to lidocaine or other narcotic drugs, epinephrine or antibiotics; 11. Suffering from collagen vascular disease; 12. Implanted cardiac pacemaker or internal defibrillator; 13. Mental disease patients, alcoholism, drug addiction; 14. Serious comorbidities, such as marked lymphadenopathy, hormonal imbalance, heart disease, diabetes (type I or II), lupus, porphyria, or related neurological disorders (i.e. treatment or healing process of any disease); 15. Patients with active malignant tumor or a history of malignant tumor within the past 5 years, or a history of cancer requiring lymph node biopsy or autopsy; 16. Subjects who received systemic glucocorticoid therapy 6 months before or throughout the course of treatment; 17. Women who are pregnant, breastfeeding or planning to become pregnant during the study period; 18. Positive test for hepatitis B, hepatitis C, syphilis or AIDS; 19. Those who have participated in other clinical trials of drugs or medical devices within three months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial Fitzpatrick Wrinkling and degree of Elastosis Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global aesthetic improvement scale;Visual Analogue Scale/Score;Subjects' evaluation of global cosmetic comments;Subjects' satisfaction;product performance evaluation;Percentage distribution of facial Fitzpatrick wrinkle and elasticity scores with an improvement of >=1 point from baseline;Improvement of the Facial Fitzpatrick Wrinkle and Elasticity Score compared to baseline; | — |
Countries
China
Contacts
Public ContactTong Lin
Hospital for skin diseases, institute of dermatology Chinese Academy of Medical Sciences, Peking Union Medical College
Outcome results
None listed