Botox Cosmetic and the Young Patient With Glabellar Furrows

NCT ID: NCT00856999

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-08
• Study Completion Date: 2010-11-17

Brief Summary

The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.

Conditions

Glabellar Furrows

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botox

Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Group Type: EXPERIMENTAL

Botox

Intervention Type: DRUG

Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Interventions

Botox

Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female
• Fitzpatrick Skin Types I-III
• Between 30 and 50 years of age
• At least moderate severity at maximum frown

Exclusion Criteria

• Prior botulinum toxin treatment
• Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
• Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
• Allergy or sensitivity to any study component
• Participation in another clinical study within 30 days of the study start date
• Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Roger Dailey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roger Dailey, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Other Identifiers

AGNR-08-0093

Identifier Type: -

Identifier Source: org_study_id