Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT06844760
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2025-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area
Sponsor:
Espad Pharmed
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: