NCT00856414

Brief Summary

This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

December 12, 2011

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

March 4, 2009

Results QC Date

September 22, 2011

Last Update Submit

January 9, 2019

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (2)

  • The First Visit Onset of Efficacy as Measured by Physician Assessment

    The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question "Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.

    14 Days

  • The First Visit Onset of Efficacy as Measured by Subject Assessment

    The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question "Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.

    14 Days

Secondary Outcomes (3)

  • Average Subject Assessment Score in Improvement of Appearance of Frown Lines

    14 Days

  • Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score

    Baseline, Day 14

  • Percentage of Patients Reporting Self-Perception of Age (SPA)

    Baseline, Day 14

Study Arms (1)

1

EXPERIMENTAL

botulinum toxin Type A 20U

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type ABIOLOGICAL

20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)

Also known as: BOTOX®
1

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects of any race, 35-55 years of age
  • Moderate to severe glabellar wrinkles (lines between the eyebrows)

You may not qualify if:

  • Previous botulinum toxin therapy
  • Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
  • Subjects planning a facial cosmetic procedure or visible scars
  • Previous cosmetic surgery to the upper face
  • Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
  • History of facial nerve palsy
  • Allergy or sensitivity to any component of the study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Livonia, Michigan, United States

Location

Related Publications (1)

  • Beer KR, Boyd C, Patel RK, Bowen B, James SP, Brin MF. Rapid onset of response and patient-reported outcomes after onabotulinumtoxinA treatment of moderate-to-severe glabellar lines. J Drugs Dermatol. 2011 Jan;10(1):39-44.

    PMID: 21197522BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Vice President, Medical Affairs
Organization
Allergan, Inc.
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 29, 2019

Results First Posted

December 12, 2011

Record last verified: 2019-01

Locations

US(2)