Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509477
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None