Overview

Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration.

Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Carruthers Dermatology Centre
Collaborator:
Allergan
Treatments:
abobotulinumtoxinA
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
Inclusion Criteria:

- Female outpatients; at least 18 years of age

- Subjects of childbearing potential must have a negative urine pregnancy test result at
the Baseline/Screening Visit and practice a reliable method of contraception
throughout the study.

- Bilaterally symmetric moderate (score 2 on Allergan Photonumeric Guide for Crow's
Feet) Lateral Orbital Rhytides at maximum smile

Exclusion Criteria:

- Subjects who are pregnant, are planning a pregnancy during the study period, have an
infant they are breast feeding, or who are of childbearing potential and not
practicing a reliable method of birth control.

- Subjects with a history of injection to the lateral orbital area with botulinum toxin
type A within one year of baseline visit.

- Subjects with a history of adverse reaction to botulinum toxin type A.

- Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert syndrome, Amyotrophic
Lateral Sclerosis, or any other disease which might interfere with neuromuscular
transmission.

- Subjects with a history of facial nerve palsy.

- Subjects with profound atrophy or excessive weakness of muscles in the target areas
for injections.

- Subjects with a systemic infection or an infection at the injection site.