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Completed

NCT Number: 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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orchid Pharmed, Medical Department

Tehran, 19947-66411, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.)

Device

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

Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)

Device

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

Primary outcomes

  1. Mean Level of Improvement From Baseline in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)

    Time frame: 24 weeks

    The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds

Secondary outcomes

  1. Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS)

    Time frame: 24 weeks

    The scores are from 1 to 5, 1 indicating exceptional improvement and 5 indicating worsened results

  2. Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)

    Time frame: 24 weeks

    ≥1-point reduction from baseline. The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds

  3. The Injected Volume to Obtain Optimal Aesthetic Result

    Time frame: 2 weeks

    initial treatment + touch-up

  4. The Number of NLFs Receiving Touch-up Treatment

    Time frame: 2 weeks

    Counting the number of NLF who need additional injection

  5. Evaluation of Adverse Events During 24 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Espad Pharmed

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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