Moderate to severe nasolabial folds
Conditions
Interventions
Treatment group:Treatment with injectable polycaprolactone microsphere filler produced by Shandong Jikun Biopharmaceutical Co., Ltd.
Control group:Treatment with the injectable polycaprolactone microsphere facial filler produced by AQTIS Medical B.V.
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years and =65 years, gender not limited; (2) Have a need to correct nasolabial folds; (3) The severity of nasolabial folds on both sides is graded as 3 or 4 on a 5-point scale (WSRS); (4) Agree not to undertake any medical aesthetic treatments that may affect the evaluation of efficacy or increase the risk of treatment, or significantly change skincare habits during the trial period; (5) The subject understands the clinical trial and voluntarily participates, signing an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of tattoos, scars, piercings, deformities, open wounds, active skin diseases or skin inflammations, or facial skin infectious diseases (such as eczema, acne, contact dermatitis, atopic dermatitis, herpes simplex, psoriasis, shingles, vitiligo, etc.), cancer or precancerous lesions in the nasolabial folds or adjacent areas and the nose, which may affect the evaluation of efficacy or increase the risk of treatment. (2) Having undergone plastic surgery in the nasolabial folds or adjacent areas and the nose, and deemed unsuitable for enrollment by the investigator. (3) Within 2 years prior to screening, having received any permanent or semi-permanent filler injections (such as polymethyl methacrylate, polyvinyl alcohol, calcium hydroxylapatite, poly-L-lactic acid, polycaprolactone, etc.), autologous fat grafting, facial lifting (including thread lifting), etc., in the nasolabial folds or adjacent areas. (4) Within 1 year prior to screening, having received injections of other temporary fillers such as hyaluronic acid, collagen, or acellular matrix in the skin of the nasolabial folds or adjacent areas. (5) Within 6 months prior to screening, having received injections of Botulinum toxin type A, radiofrequency treatment, or ultrasound treatment in the nasolabial folds or adjacent areas. (6) Within 3 months prior to screening, having received mesotherapy or chemical peeling, fractional laser, or intense pulsed light treatment in the nasolabial folds or adjacent areas. (7) Individuals prone to keloid formation, hypertrophic scarring, or any other abnormal healing. (8) Allergic to drugs involved in the trial (such as local anesthetic lidocaine or other amide-type anesthetics), trial products (such as hyaluronic acid, polycaprolactone, etc.), or currently experiencing an allergic episode. (9) Severe liver or kidney dysfunction (such as alanine aminotransferase or aspartate aminotransferase > twice the upper limit of normal; creatinine > 1.5 times the upper limit of normal). (10) Clinically significant coagulation dysfunction, having received thrombolytic, anticoagulant, or antiplatelet aggregation treatment within 2 weeks prior to injection, or requiring such treatment within 2 weeks after injection. (11) Having received chemotherapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies), or systemic corticosteroid treatment within 3 months prior to screening (but inhaled corticosteroids are allowed). (12) Having received local (nasolabial folds or adjacent areas) retinoids or corticosteroid treatment within 1 month prior to screening, or having received systemic retinoid treatment within 6 months prior to screening. (13) Presence of unidentified injectable substances in the treatment area. (14) Planning to undertake any interventions during the trial period that may lead to significant changes in body weight (weight change =10%). (15) Pregnant women, nursing women, and those planning to conceive during the trial period. (16) Comorbid cognitive or psychiatric disorders that prevent understanding and cooperation. (17) Having participated in another therapeutic clinical trial within 1 month prior to informed consent and not having reached the primary endpoint. (18) Subjects deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Effectiveness Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in WSRS score;WSRS Score Improvement Rate;Global Aesthetic Improvement Scale (GAIS) Evaluation; | — |
Countries
China
Contacts
Public ContactWang Hang
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed