Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

Allergan40 enrolled

Overview

This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Glabellar Frown Lines

Interventions

botulinum toxin Type ABIOLOGICAL

botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

normal saline (placebo)DRUG

Normal saline (placebo) injected into the glabellar region on Day 0.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe glabellar wrinkles (frown lines) Exclusion Criteria: * Previous treatment with botulinum toxin therapy of any serotype * Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months * Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months * Mid-facial or periorbital treatment with non-permanent soft tissue fillers * Subjects planning a facial cosmetic procedure or visible scars * Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery) * Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * History of facial nerve palsy * A planned extended absence during the study

Locations (1)

Unnamed facility

East Chicago, Illinois, United States

Outcomes

Primary Outcomes

Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30

Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.

Time frame: Day 30

Secondary Outcomes

Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30

The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.

Time frame: Day 30

Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60

The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.

Time frame: Day 60

Data from ClinicalTrials.gov

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