labia majora atrophy
Conditions
Interventions
Experimental group:Hyaluronic acid injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Adult females (>=18 years old); 2) Those who were diagnosed as moderate or severe labia major atrophy or hypoplasia (labia major atrophy grade 2-3) and wished to be corrected; 3) They volunteered to participate in the study and signed the informed consent. They fully understood the content, process and possible adverse reactions of the trial, and agreed to participate in all visits, examinations and treatment according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1) Pregnant, lactating and puerperal women; 2) Patients with severe psychological disorder, mental disorder, personality disorder or patients taking antipsychotic drugs; 3) Patients with severe diseases of main organs (cardiovascular system, lung, liver, kidney and nervous system, etc.); 4) Patients with diabetes, hematological diseases and immune diseases, and abnormal coagulation function; 5) Patients with systemic and interventional site infection; 6) Patients with infectious skin diseases such as vulvar soft wart, acute vaginitis, cervicitis, and abnormal cervical cancer screening; 7) Patients with sexually transmitted diseases, such as HIV, condyloma acuminatum, active syphilis, genital herpes, etc; 8) History of vulvar cancer and radiotherapy; 9) Patients with neoplasm, scar, wound and keloid constitution (easy to form keloid and hypertrophic scar) on labia major; 10) The labia major has been treated with the following procedures: The labia major was injected with degradable fillers or implanted with long-acting fillers within one year; History of fat injection in labia major; History of exfoliative treatment of labia major within half a year; 11) The skin of labia major is severely flabby and excessively loose; 12) Patients planning to undergo perineal treatment and operation during the trial period, such as injection of other fillers in labia major, labiaplasty, laser bleaching of vulva, etc; 13) Those who took large dose of anticoagulant drugs or hormones within 30 days before injection; 14) Those who have participated in other clinical trial within 30 days before signing the informed consent; 15) Those who are allergic to hyaluronic acid or other materials involved in this test and have a history of granuloma; 16) Pelvic correction was planned during the treatment; 17) Patients with other conditions that are not suitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate 3 months after injection, calculated from Global Aesthetic Improvement Scale, evaluated by third-party; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate calculated from Global Aesthetic Improvement Scale, evaluated by third-party;Effective rate calculated from Global Aesthetic Improvement Scale, evaluated by researcher;Effective rate calculated from Global Aesthetic Improvement Scale, evaluated by the subject;Improvement of labia majora atrophy, evaluated by researcher;Changes on Female Sexual Function Index;Changes on vulvar symptoms;Level of pain during injection; | — |
Countries
China
Contacts
Public ContactLong Xiao
Peking Union Medical College Hospital
Outcome results
None listed