Forehead wrinkles Forehead wrinkle
Conditions
Interventions
Participants receive Poly D,L-lactic acid (PDLLA
Juvelook) injection into the forehead using a 25G blunt cannula. A total volume of 6 mL (PDLLA 42.5 mg reconstituted with normal saline) is injected into the hypodermis to subcutaneous layer once mont
Experimental Device
Poly D,L-lactic Acid Injection
Sponsors
Division of Dermatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older. 2. In good general health without serious underlying disease. 3. Clinically visible static forehead wrinkles or Grade 2 or higher on the Allergan Forehead Lines Scale. 4. Able to attend follow-up visits and comply with study procedures. 5. Willing to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Forehead wrinkle treatment with laser, ultrasound, radiofrequency, filler, or any biostimulator within 1 year before treatment, or botulinum toxin injection within 6 months. 2. Use of facial skincare products that stimulate collagen production, such as retinoids or vitamin C. 3. Active forehead skin infection or inflammation not resolved at least 1 month before treatment. 4. Wound or open lesion on the forehead. 5. Active inflammatory skin disease, including psoriasis, cutaneous lupus erythematosus, eczema, vitiligo, or rosacea. 6. History of skin cancer. 7. History of keloid scarring. 8. History of recurrent herpes infection. 9. Coagulation disorder or current use of antiplatelet or anticoagulant medication. 10. History of allergy to PDLLA. 11. Pregnancy or breastfeeding. 12. Refusal or withdrawal from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in forehead wrinkles Baseline, Days 30, 60, 90, 120, 150, and 180 Forehead wrinkles are assessed using Allergan Forehead Lines Scale, Forehead line dynamic grading scale, and Antera 3D indentation index. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and side effects Baseline, Days 30, 60, 90, 120, 150, and 180 Assessed by physician and participant report at treatment and follow-up visits.,Pain score immediately after each treatment session on Days 0, 30, and 60 Visual Analog Scale,Patient satisfaction Days 30, 60, 90, 120, 150, and 180 patient satisfaction score,Patient's and physician's Global Aesthetic Improvement Scale Days 30, 60, 90, 120, 150, and 180 Global Aesthetic Improvement Scale | — |
Countries
Thailand
Contacts
Public ContactVasanop Vachiramon
Division of Dermatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed