Botox Cosmetic and the Young Patient With Glabellar Furrows

Phase 4

Completed

• Conditions: Glabellar Furrows
• Interventions: Drug: Botox

• Registration Number: NCT00856999
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-08
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-06
• Primary Completion: 2010-11-17
• Study Completion: 2010-11-17
• Results First Submitted: 2019-05-01
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-01
• Last Update Submitted: 2019-07-01
• Results First Posted: 2019-07-23
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botox	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

Primary Outcome Measures

Name	Time	Method
Reduction of the Facial Wrinkle Scale	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	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