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

NCT ID: NCT06509477

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-11-11

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.

Conditions

Moderate or Severe Nasolabial Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.)

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

Hyaluronic 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

Intervention Type: DEVICE

Hyaluronic 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Espad Pharmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kamran Balighi, Prof. Derm

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Locations

Orchid Pharmed, Medical Department

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

LUN.ESP.KB.IV.00

Identifier Type: -

Identifier Source: org_study_id