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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Espad Pharmed · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
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

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-11-11
• Completion: 2023-11-11
• First posted: 2024-07-19
• Last updated: 2026-02-03
• Results posted: 2026-02-03

Locations

1 site across 1 country: Iran