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

Skin Wrinkling Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250952
• Other study ID #: CCR-001
• Status: Completed
• Phase: N/A
• First received: November 7, 2005
• Last updated: November 8, 2005
• Start date: February 2005
• Est. completion date: June 2005

Study information

• Verified date: November 2005
• Source: Carruthers Dermatology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Skin Wrinkling

Intervention

Drug:
• Botox Cosmetic™

Locations

Country	Name	City	State
Canada	Carruthers Dermatology Centre, Inc.	Vancouver	British Columbia
United States	Skin Care Physicians of Chestnut Hill	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Carruthers Dermatology Centre	Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.