Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250952
Status:
COMPLETED
Last Update Posted:
2005-11-09
First Post:
2005-11-07
Brief Title:
Study to Determine If the Volume Used to Dilute BOTOX Cosmetic for Injection Affects Its Overall Effect and Duration
Sponsor:
Carruthers Dermatology Centre
Organization:
Carruthers Dermatology Centre
Study Overview
Official Title:
A Randomized Evaluator-Blinded Two Centre Study of the Safety and Effect of Volume on the Diffusion and Efficacy of BOTOX Cosmetic Botulinum Toxin Type A in the Treatment of Lateral Orbital Rhytides
Status:
COMPLETED
Status Verified Date:
2005-11
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:
It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides even though the dose remains the same
The study was designed to test this thinking using the crows feet wrinkles as the treatment area
The study was designed to test this thinking using the crows feet wrinkles as the treatment area
Detailed Description:
It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides even though the dose remains the same
20 female subjects 10 per site who fit the inclusionexclusion criteria for study participation were injected with 5 units of Botox one injection each side into the crows feet area The injections were prepared with one side randomly receiving a five fold difference in volume for dilution
Response to treatment was evaluated at 14 days 30 days 60 days and 90 days after the injection visit Standardized photography was taken at each visit
Analysis of the photographs of the lateral orbital crows feet rhytides at maximum attempted contraction maximum smile was done by Canfield Scientific Inc using a specialized software program created to detect and measure changes
20 female subjects 10 per site who fit the inclusionexclusion criteria for study participation were injected with 5 units of Botox one injection each side into the crows feet area The injections were prepared with one side randomly receiving a five fold difference in volume for dilution
Response to treatment was evaluated at 14 days 30 days 60 days and 90 days after the injection visit Standardized photography was taken at each visit
Analysis of the photographs of the lateral orbital crows feet rhytides at maximum attempted contraction maximum smile was done by Canfield Scientific Inc using a specialized software program created to detect and measure changes
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