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

November 8, 2005 updated by: Carruthers Dermatology Centre

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.

Study Overview

Status

Completed

Conditions

Skin Wrinkling

Intervention / Treatment

Drug: Botox Cosmetic™

Detailed Description

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.

Study Type

Interventional

Enrollment

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E1
    - Carruthers Dermatology Centre, Inc.
United States
- Massachusetts
  - Chestnut Hill, Massachusetts, United States, 02467
    - Skin Care Physicians of Chestnut Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carruthers Dermatology Centre

Collaborators

Allergan

Investigators

Principal Investigator: J. Alastair Carruthers, MD, Carruthers Dermatology Centre, Inc.
Principal Investigator: Jeffrey S Dover, MD, Skin Care Physicians of Chestnut Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

November 7, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 9, 2005

Study Record Updates

Last Update Posted (Estimate)

November 9, 2005

Last Update Submitted That Met QC Criteria

November 8, 2005

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Clinical Practice Variations

Additional Relevant MeSH Terms

Other Study ID Numbers

CCR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.