Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration.
Information source: Carruthers Dermatology Centre
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Wrinkling
Intervention: Botox Cosmetic™ (Drug)
Phase: N/A
Status: Completed
Sponsored by: Carruthers Dermatology Centre Official(s) and/or principal investigator(s):
J. Alastair Carruthers, MD, Principal Investigator, Affiliation: Carruthers Dermatology Centre, Inc.
Jeffrey S Dover, MD, Principal Investigator, Affiliation: Skin Care Physicians of Chestnut Hill
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.
Clinical Details
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.
Study design: Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Using the per visit photographs, the effect of Botox was measured separately for each treatment site (right and left crow's feet at maximum smile) for all visits.
Secondary outcome: Using the per visit photographs, the remaining effect of Botox treatment was measured separately for each treatment site (right and left crow's feet at maximum smile) for the 30, 60, and 90 day follow up visits.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Carruthers Dermatology Centre, Inc., Vancouver, British Columbia V5Z 4E1, Canada
Skin Care Physicians of Chestnut Hill, Chestnut Hill, Massachusetts 02467, United States
Additional Information
Starting date: February 2005
Ending date: June 2005
Last updated: November 8, 2005
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