Trials / Completed
CompletedNCT00250952
Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration.
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (planned)
- Sponsor
- Carruthers Dermatology Centre · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 crow's 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 inclusion/exclusion criteria for study participation were injected with 5 units of Botox (one injection each side) into the crow's 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 (crow's 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Botox Cosmetic™ |
Timeline
- Start date
- 2005-02-01
- Completion
- 2005-06-01
- First posted
- 2005-11-09
- Last updated
- 2005-11-09
Locations
2 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00250952. Inclusion in this directory is not an endorsement.