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

November 7, 2005
November 8, 2005
February 2005
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00250952 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration.
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Skin Wrinkling
Drug: Botox Cosmetic™
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2005
Not Provided

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00250952
CCR-001
Not Provided
Not Provided
Carruthers Dermatology Centre
Allergan
Principal Investigator: J. Alastair Carruthers, MD Carruthers Dermatology Centre, Inc.
Principal Investigator: Jeffrey S Dover, MD Skin Care Physicians of Chestnut Hill
Carruthers Dermatology Centre
November 2005

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