Rationale and background: Skin aging is a complex process that results in various changes in the skin, including wrinkles, sun spots, and sagging skin. The NLF is a natural change that becomes more prominent with aging and significantly affects the beauty of the facial skin. Dermal fillers, particularly hyaluronic acid (HA) fillers, are commonly used to correct these signs of aging. This study aimed to compare the effectiveness and safety of Lunaphil Ultra with Juvederm Ultra 4® for treating NLFs. Primary objective: Effectiveness assessment of Lunaphil Ultra Secondary objectives: Effectiveness and safety assessment of Lunaphil Ultra Study design: This is a randomized, double-masked, active controlled, within-subject, and equivalency clinical trial. Setting: Subjects were treated with Lunaphil Ultra in one NLF and Juvederm Ultra 4® in the opposite NLF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Two treatments will be allowed over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs based on investigator's opinion
Two treatments will be allowed over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs based on investigator's opinion
Orchid Pharmed, Medical Department
Tehran, Iran
Mean Level of Improvement From Baseline in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)
The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds
Time frame: 24 weeks
Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS)
The scores are from 1 to 5, 1 indicating exceptional improvement and 5 indicating worsened results
Time frame: 24 weeks
Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)
≥1-point reduction from baseline. The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds
Time frame: 24 weeks
The Injected Volume to Obtain Optimal Aesthetic Result
initial treatment + touch-up
Time frame: 2 weeks
The Number of NLFs Receiving Touch-up Treatment
Counting the number of NLF who need additional injection
Time frame: 2 weeks
Evaluation of Adverse Events During 24 Weeks
All reported AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA) terms and are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.