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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
  Purpose

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.


Condition Intervention
Skin Wrinkling
 Drug: Botox Cosmetic™

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carruthers Dermatology Centre:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 20
Study Start Date: February 2005
Estimated Study Completion Date: June 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250952

Locations
United States, Massachusetts
Skin Care Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
Canada, British Columbia
Carruthers Dermatology Centre, Inc.
Vancouver, British Columbia, Canada, V5Z 4E1
Sponsors and Collaborators
Carruthers Dermatology Centre
Allergan
Investigators
Principal Investigator: J. Alastair Carruthers, MD Carruthers Dermatology Centre, Inc.
Principal Investigator: Jeffrey S Dover, MD Skin Care Physicians of Chestnut Hill
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00250952     History of Changes
Other Study ID Numbers: CCR-001
Study First Received: November 7, 2005
Last Updated: November 8, 2005
Health Authority: Canada: Health Canada
United States: Institutional Review Board

Keywords provided by Carruthers Dermatology Centre:
Clinical Practice Variations

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013