Status:
COMPLETED
Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration.
Lead Sponsor:
Carruthers Dermatology Centre
Collaborating Sponsors:
Allergan
Conditions:
Skin Wrinkling
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00250952
Start Date
February 1 2005
End Date
June 1 2005
Last Update
November 9 2005
Active Locations (2)
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1
Skin Care Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
2
Carruthers Dermatology Centre, Inc.
Vancouver, British Columbia, Canada, V5Z 4E1