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

NCT00250952 | Completed

• 1 other identifier: CCR-001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

Skin Wrinkling

Keywords

Clinical Practice Variations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Botox Cosmetic™ DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carruthers Dermatology Centre: lead
• Allergan: collaborator

Study Sites (2)

Skin Care Physicians of Chestnut Hill

Chestnut Hill, Massachusetts, 02467, United States

Location

Carruthers Dermatology Centre, Inc.

Vancouver, British Columbia, V5Z 4E1, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• J. Alastair Carruthers, MD

  Carruthers Dermatology Centre, Inc.

  PRINCIPAL INVESTIGATOR

• Jeffrey S Dover, MD

  Skin Care Physicians of Chestnut Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 9, 2005
• Study Start: February 1, 2005
• Study Completion: June 1, 2005
• Last Updated: November 9, 2005

Record last verified: 2005-11

Locations

US (1); CA (1)