Moderate to severe labia majora atrophy or dysplasia
Conditions
Interventions
Experimental group:Injection of hyaluronate acid
Control group:None
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
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. Patients during pregnancy, breastfeeding and puerperium and those who have a pregnancy plan in the last 1 year; 2. Patients suffering from severe mental abnormality, psychological disorder, personality disorder or taking antipsychotic drugs; 3. Patients with a history of serious diseases of important organs (cardiovascular system, lung, liver, kidney and nervous system, etc.); 4. Patients with diabetes, autoimmune diseases or abnormal coagulation function; 5. There are systemic and treatment site infections; 6. Patients with infectious skin diseases such as mollocum contagiosus of the vulva, acute vaginitis, cervicitis and abnormal cervical cancer screening; 7. Suffering from sexually transmitted diseases, such as HIV, condyloma acuminatum, active syphilis, genital herpes, etc.; 8. Patients with a history of vulvar cancer or external radiation therapy; 9. Patients with new organisms, scars, wounds and scar constitution (keloid and hypertrophic scar easily formed) in labia majora; 10. The following treatments or operators have been performed on the labia majora: (1) The labia majora has had biodegradable fillers injected within one year, or has had long-acting fillers implanted; (2) A history of fat filling in the labia majora; (3) History of epidermal exfoliation of labia majora within 1 month; 11. Perineal treatment and operations are planned during the trial, such as injection of other fillers on the labia majora, reduction and plastic surgery on the labia minora, laser bleaching of the vulva, etc.; 12. Patients who have received thrombolytic therapy, anticoagulant therapy, antiplatelet aggregation therapy or hormone therapy within 2 weeks before injection; 13. Participated in any other clinical trial within 30 days prior to signing the informed consent; 14. Patients who are allergic to hyaluronic acid or have a history of allergy and granuloma to other materials involved in this test; 15. Those who plan to undergo pelvic correction during treatment; 16. Patients with other conditions shall be deemed unsuitable for this clinical trial by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective correction of labia majora atrophy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency and safety; | — |
Countries
China
Contacts
Public ContactLian Guihua
Outcome results
None listed