Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT02108158
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2014-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
A Randomized, Evaluator-blinded, Comparative Study to Evaluate the Efficacy and Safety of Different Injection Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines
Status:
COMPLETED
Status Verified Date:
2015-08
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:
A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.
Detailed Description:
Clarification regarding injection volumes for the different study groups:
Subjects will be randomized to Group A or Group B (1:1).
* Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be injected (equal to a dose of 10s.U.)
* Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be injected (equal to a dose of 10s.U.).
The two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A) will be compared as described under objectives.
Subjects will be randomized to Group A or Group B (1:1).
* Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be injected (equal to a dose of 10s.U.)
* Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be injected (equal to a dose of 10s.U.).
The two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A) will be compared as described under objectives.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-004646-42 | EUDRACT_NUMBER | None | View |