Clinical trial NCT06509477: Effectiveness and Safety Comparison of Lunaphil Ultra (Hyaluronic Acid, by Espad Pharmed Co.) Versus Juvederm Ultra 4® (Hyaluronic Acid, by Allergan Co.) in Nasolabial Folds (NLFs) Management
Official title: A Randomized, Double-masked, Active Controlled, Within-subject Equivalency Clinical Trial to Compare Effectiveness and Safety of Lunaphil Ultra (Hyaluronic Acid, Produced by Espad Pharmed Co.) Versus Juvederm Ultra 4® (Hyaluronic Acid, Produced by Allergan Co.) for the Management of Moderate or Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate or Severe Nasolabial Folds
Lead sponsor: Espad Pharmed
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 104
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean level of improvement from baseline in NLF severity score by Wrinkle Severity Rating Scale (WSRS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of subjects with an improved score from baseline based on Physician Global Aesthetic Improvement Scale (PGAIS)
timeFrame: 24 weeks
measure: Proportion of NLFs maintaining a clinically significant improvement in NLF severity score by Wrinkle Severity Rating Scale (WSRS)
timeFrame: 24 weeks
measure: The injected volume to obtain optimal aesthetic result
timeFrame: 2 weeks
measure: The number of NLFs receiving touch-up treatment
timeFrame: 2 weeks
measure: Evaluation of adverse events during 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Orchid Pharmed, Medical Department
Study officials:
affiliation: Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.
name: Kamran Balighi, Prof. Derm
role: PRINCIPAL_INVESTIGATOR
References: