Efficacy and safety of two hyaluronic acid fillers for the treatment of moderate-to-severe nasolabial folds in a Chinese populatio
- Conditions
- Moderate-to-severe nasolabial folds in Chinese patientsSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN11835676
- Lead Sponsor
- Beijing Tsinghua Chang Gung Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 339
1. Male and female subjects aged 18-65 years
2. Nasolabial crease WSRS grade 3-4 and wish to correct the subject
3. Subjects with nasolabial crease of the same WSRS grade on both sides
4. Participants who agreed not to use other cosmetic treatments related to the study
5. Understand and comply with the requirements of the trial, can complete the whole follow-up process of the subjects
6. Volunteer to participate in the study and sign the informed consent form
1. Pregnant or lactating women
2. Women of childbearing age who did not agree to use medically approved contraceptive methods (e.g. oral contraceptives, condom, intrauterine device) during the trial
3. The abnormal laboratory results were judged by the researcher as having clinical significance
4. Subjects with scarring or skin diseases in the trial treatment area that may affect the judgment of treatment efficacy, or with active inflammation and/or unhealed wounds
5. Subjects with active inflammation and skin infection in the experimental treatment area
6. Subjects who had received silicone or other permanent dermal fillers in the treatment area
7. Subjects who had undergone facial lifting surgery or catgut-embedding surgery within 1 year of the screening period
8. The subjects were treated with sodium hyaluronate or other semi-permanent dermal fillers within 1 year before the screening period
9. Within 6 months before the screening period, the subjects underwent other treatments such as botulinum toxin injection, radiofrequency ablation, focused ultrasound, laser peels, grinding, chemical peeling, etc
10. Participants who had used anticoagulant, antiplatelet, or thrombolytic therapy (e.g. , Warfarin, aspirin) within 14 days before study treatment or planned to use it within 3 days after study treatment
11. Had a history of multiple severe allergies, a history of inherited allergies, a history of allergy to hyaluronic acid products or streptococcal protein, and planned desensitization treatment during the study period
12. The subjects had a history of serious diseases of their vital organs or autoimmune diseases
13. The subjects had a history of hypertrophic scar or scar formation
14. Subjects who had participated in other clinical trials within 30 days before the screening period
15. The study participants were considered unsuitable for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The response rate of NLF correction at week 24 after the last injection treatment. The response rate was characterized as the percentage of subjects exhibiting an improvement of at least one-point based on the Wrinkle Severity Rating Scale (WSRS) assessed by a blinded evaluator.
- Secondary Outcome Measures
Name Time Method 1. Wrinkle severity evaluated on the WSRS by a blinded evaluator at Week 4, 12, and 52<br>2. Aesthetic improvement evaluated on the Global Aesthetic Improvement Scale (GAIS) by both subjects and a blinded evaluator at Week 4, 12, 24 and 52