nasolabial fold
Conditions
Interventions
Test group:Sodium Hyaluronate Gel for Injection
Control Group:Sodium Hyaluronate Gel for Injection
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male or female at the age of 18~65 years; 2.Volunteers whose nasolabial folds on both sides of the face are obvious, requiring stuffing and repairing operation; 3.The intensity of nasolabial folds on both sides of the face is classified to Grade 3 or Grade 4; 4.Subjects are willing to abide by study guidance and cooperate with clinical follow-up visits; 5.Subjects are willing to take part in the test and sign Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1.Female subjects who are pregnant or breastfeeding or who are going to become pregnant during the trial; 2.There are obvious acne scars, active inflammation, infection, cancerous or precancerous lesions or unhealed wounds in the nasolabial fold area; 3.Nasolabial fold wrinkles have been filled with silicone or other permanent and semi-permanent dermal fillers; 4.Perform facial lift surgery or other surgical treatments to improve the nasolabial fold area within 6 months before the study injection or during the trial period; 5.Other types of wrinkle treatments, such as botulinum toxin treatment (Botox injection), laser skin resurfacing, grinding, chemical peeling, etc., should be performed on the treatment site within 6 months before the study injection or during the trial period; 6.Are receiving immunosuppressive therapy; 7.Locally suffering from other active skin diseases in the past 6 months, such as infection, local wounds, psoriasis and herpes simplex, etc.; 8.Scar constitution; 9.There is a history of serious diseases of important organs (cardiovascular system, liver, lung, nervous system, kidney, etc.), or a history of abnormal immune function (such as autoimmune disease, low immune function); 10.Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening; 11.A history of severe allergic reactions, a history of hereditary allergies, a history of allergies to hyaluronic acid products or severe allergic reactions to multiple substances, showing severe allergic reactions; 12.The investigator believes that it is not suitable for participants, such as participation in the trial may put the participants at a significant risk, may confuse the results of the study, the participants have unrealistic expectations or have obvious psychological disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial improvement score; | — |
Countries
China
Contacts
Public ContactLi Linfeng
Department of Dermatology, Beijing Friendship
Outcome results
None listed