Botox Cosmetic and the Young Patient With Glabellar Furrows

Oregon Health and Science University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glabellar Furrows

Interventions

BotoxDRUG

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

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Reduction of the Facial Wrinkle Scale

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

Time frame: 26 months

Patient Assessed Frown-line Improvement

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

Time frame: 20 months

Data from ClinicalTrials.gov

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