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

Not Applicable

Completed

• Conditions: Moderate or Severe Nasolabial Folds
• Interventions: Device: Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.); Device: Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)

• Registration Number: NCT06509477
• Lead Sponsor: Espad Pharmed

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-11-11
• Study Completion: 2023-11-11
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-19
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lunaphil Ultra (by Espad Pharmed Co.)	Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.)	Lunaphil Ultra (by Espad Pharmed Co.) will be administered over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs. In case of suboptimal correction of NLFs at week 2 after the initial treatment, the treating investigator will be directed to retreat the under corrected NLF(s).
Juvederm Ultra 4® (by Allergan Co.)	Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)	Juvederm Ultra 4® (by Allergan Co.) will be administered over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs. In case of suboptimal correction of NLFs at week 2 after the initial treatment, the treating investigator will be directed to retreat the under corrected NLF(s).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
The number of NLFs receiving touch-up treatment	2 weeks	Counting the number of subject 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.
Proportion 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

Trial Locations

Locations (1)

Orchid Pharmed, Medical Department; 🇮🇷 Tehran, Iran, Islamic Republic of