Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines

This study is currently recruiting participants.

Verified by Allergan, March 2009

First Received: March 4, 2009 No Changes Posted

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00856414

Purpose

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)

Condition	Intervention	Phase
Skin Aging	Biological: botulinum toxin type A	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Botox Skin Aging

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Onset of efficacy will be measured by patient diary and physician assessment at clinic visits [ Time Frame: Days 2,3,4,7,14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient satisfaction will be measured by FLO, SPA and PGA [ Time Frame: Days 2, 3, 4, 7, 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: botulinum toxin type A 20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)

Eligibility

Ages Eligible for Study:	35 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856414

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, Florida
	Recruiting
West Palm Beach, Florida, United States
United States, Michigan
	Recruiting
Livonia, Michigan, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Vice President Medical Affairs )
Study ID Numbers:	MA-BTX-0806
Study First Received:	March 4, 2009
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00856414 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Botulinum Toxins
Peripheral Nervous System Agents
Botulinum Toxin Type A

Additional relevant MeSH terms:

Botulinum Toxins
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009