Skin Wrinkling Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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