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

This study has been completed.

Sponsor:

Collaborator:

Allergan

Information provided by:

Carruthers Dermatology Centre

ClinicalTrials.gov Identifier:

NCT00250952

First received: November 7, 2005

Last updated: November 8, 2005

Last verified: November 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

November 7, 2005

Last Updated Date

November 8, 2005

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00250952 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 dose remains the same.

The study was designed to test this thinking, using the crow's feet wrinkles as the treatment area.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Skin Wrinkling

Intervention ^ICMJE

Drug: Botox Cosmetic™

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00250952

Other Study ID Numbers ^ICMJE

CCR-001

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Carruthers Dermatology Centre

Collaborators ^ICMJE

Allergan

Investigators ^ICMJE

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

Information Provided By

Carruthers Dermatology Centre

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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