Moderate or Severe Nasolabial Folds
Conditions
Brief summary
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.
Interventions
DEVICEHyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.)
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
DEVICEHyaluronic acid Juvederm Ultra 4® (by Allergan Co.)
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
Sponsors
Espad Pharmed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a randomized, double-masked, active controlled, within-subject, paired, and equivalency clinical trial. Subjects were treated with Lunaphil Ultra in one NLF and Juvederm Ultra 4® in the opposite NLF.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects ≥ 30 years of age * Visible bilateral NLFs that were approximately symmetrical and had an equal severity ranging from moderate to severe (assessed at the deepest part) * Able to follow study instructions and likely to complete all required visits * Signed informed consent
Exclusion criteria
* History of bleeding disorders or participants receiving or recently exposed (≤ 3 weeks) to continuous treatment with thrombolytics, anticoagulants, platelet inhibitors, or NSAIDs * Acute herpetic eruption * Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders * Known sensitivity to local anesthetics of the amide type (such as lidocaine), history of hypersensitivity to gram-positive bacterial proteins, history of multiple severe allergies, history of anaphylactic shock * Known hypersensitivity to any component of the study products or excipients (like hyaluronic acid) * History of receiving immune therapy or a history of autoimmune disease * History of active chronic debilitating systemic disease * History of connective tissue disease, history of malignancy (except for non-melanoma skin cancer) within the last 5 years * Clinically significant active dermatologic disorders within the last 6 months * Use of oral retinoids, over-the-counter (OTC) or prescription antiwrinkle treatments, microdermabrasion, or chemical peels in the NLF area within the last 4 weeks or intention to use them during the study * Any prior cosmetic procedure or tissue augmentation at the NLF injection site within 1 year before study entry (or intent to undergo such a procedure during the study) * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Level of Improvement From Baseline in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS) | 24 weeks | The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS) | 24 weeks | The scores are from 1 to 5, 1 indicating exceptional improvement and 5 indicating worsened results |
| Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS) | 24 weeks | ≥1-point reduction from baseline. The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds |
| The Injected Volume to Obtain Optimal Aesthetic Result | 2 weeks | initial treatment + touch-up |
| The Number of NLFs Receiving Touch-up Treatment | 2 weeks | Counting the number of NLF who need additional injection |
| Evaluation of Adverse Events During 24 Weeks | 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. |
Countries
Iran
Contacts
PRINCIPAL_INVESTIGATORKamran Balighi, Prof. Derm
Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.39 years STANDARD_DEVIATION 10.44 |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 104 |
| other Total, other adverse events | 3 / 104 | 5 / 104 |
| serious Total, serious adverse events | 0 / 104 | 0 / 104 |
Outcome results
None listed