Completed

NCT Number: NCT00856999

Botox Cosmetic and the Young Patient With Glabellar Furrows

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.

Completed

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Key information

Conditions

Glabellar Furrows

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botox

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

Primary outcomes

Reduction of the Facial Wrinkle Scale

Time frame: 26 months

Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles)

Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase
Patient Assessed Frown-line Improvement

Time frame: 20 months

Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score)

Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

Allergan

Registry information

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2010
First posted: Mar 6, 2009
Registry last updated: Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.