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

Completed · Not applicable

Conditions studied: Skin Wrinkling

In brief

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.

Key facts

Study ID

NCT00250952

Run by

Carruthers Dermatology Centre

People needed

20

Starts

2005-02-01

Expected to finish

2005-06-01

Last updated by the study team

2005-11-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Skin Care Physicians of Chestnut Hill — Chestnut Hill, Massachusetts, United States
• Carruthers Dermatology Centre, Inc. — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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