moderate to severe atrophy or dysplasia of labia majora
Conditions
Interventions
None listed
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Adult female aged >=18 years; 2. Patients with moderate to severe labia majora atrophy or dysplasia (grade 2 to 3 for labia majora atrophy) judged by the researchers in the sub-center want correction; 3. Voluntarily participate in the study, sign the informed consent, fully understand the test content, process and possible adverse reactions, and agree to participate in all visits, examinations and treatments as required by the test plan.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breast-feeding and puerperium women and those who have a pregnancy plan in the past 1 year; 2. Those who suffer from severe mental disorders, psychological disorders, personality disorders or are taking antipsychotic drugs; 3. Those with a history of serious diseases of important organs (cardiovascular system, lung, liver, kidney and nervous system, etc.); 4. People with diabetes, autoimmune diseases or abnormal coagulation function; 5. Patients with systemic and treatment site infections; 6. Suffering from contagious skin diseases such as molluscum contagiosum, acute vaginitis, cervicitis, abnormal cervical cancer screening; 7. Suffering from sexually transmitted diseases, such as: HIV, genital warts, active syphilis, genital herpes, etc.; 8. Those with a history of vulvar cancer and radiotherapy of the vulva; 9. Those with new organisms, scars, wounds and scar constitution (easy to form keloids and hypertrophic scars) on the labia majora; 10. Those who have performed the following treatments or operations on the labia majora: (1) The labia majora has been injected with biodegradable fillers or implanted with long-acting fillers within one year; (2) Have a history of labia majora fat injection; (3) History of labia majora epidermis exfoliation within 1 month; 11. Plan to perform perineal treatment and operations during the trial period, such as: labia majora injection of other fillers, labia minora reduction plastic surgery, vulva laser bleaching, etc.; 12. Those who have received thrombolysis, anticoagulation, antiplatelet aggregation therapy or hormone therapy within 2 weeks before injection; 13. Those who have participated in any other clinical trials within 30 days before signing the informed consent form; 14. Those who are allergic to hyaluronic acid, or have a history of allergies and granulomas to other materials involved in this test; 15. Those who plan to perform pelvic correction during treatment; 16. If the subject has other circumstances, the investigator judges that he is not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective correction of labia majora atrophy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction rate of improvement in the overall cosmetic effect of the labia majora; | — |
Countries
China
Contacts
Public ContactLong Xiao
Peking Union Medical College Hospital
Outcome results
None listed