NCT06844760

Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area

Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Rejuvenation, Hydration, and Elasticity Improvement of the Neck Area

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Espad Pharmed · Industry
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement. Primary objective: Elasticity (R0, R2, and R5) improvement from baseline in neck area at weeks 8 and 16 Hypothesis: Perleux body (produced by Espad Pharmed Co.) has acceptable efficacy and safety profile for neck skin rejuvenation, elasticity improvement, and hydration enhancement. Secondary objectives: Effectiveness and safety assessment of Perleux body Study design: This is a phase IV, single-arm, and pre-post study Setting: Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.

Conditions

• Skin Aging

Interventions

Type	Name	Description
DEVICE	Hyaluronic Acid (HA)	Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.

Timeline

• Start date: 2024-07-04
• Primary completion: 2024-10-24
• Completion: 2024-10-24
• First posted: 2025-02-25
• Last updated: 2025-03-05

Locations

1 site across 1 country: Iran