Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856414

Enrollment

Registered

2009-03-05

Start date

2009-03-31

Completion date

2009-04-30

Last updated

2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Aging

Brief summary

This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)

Interventions

BIOLOGICALbotulinum toxin Type A

20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Female subjects of any race, 35-55 years of age * Moderate to severe glabellar wrinkles (lines between the eyebrows)

Exclusion criteria

* Previous botulinum toxin therapy * Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control * Subjects planning a facial cosmetic procedure or visible scars * Previous cosmetic surgery to the upper face * Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function * History of facial nerve palsy * Allergy or sensitivity to any component of the study medication

Design outcomes

Primary

Measure	Time frame	Description
The First Visit Onset of Efficacy as Measured by Physician Assessment	14 Days	The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14.
The First Visit Onset of Efficacy as Measured by Subject Assessment	14 Days	The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14.

Secondary

Measure	Time frame	Description
Average Subject Assessment Score in Improvement of Appearance of Frown Lines	14 Days	Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.
Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score	Baseline, Day 14	Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.
Percentage of Patients Reporting Self-Perception of Age (SPA)	Baseline, Day 14	Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were Looking younger, Looking current age, and Looking older. Results for each response are presented for Baseline and Day 14.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Botulinum Toxin Type A 20U botulinum toxin Type A 20U	45
Total	45

Baseline characteristics

Characteristic	Botulinum Toxin Type A 20U
Age, Continuous	43.5 years
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 45
serious Total, serious adverse events	0 / 45

Outcome results

Primary

The First Visit Onset of Efficacy as Measured by Physician Assessment

The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14.

Time frame: 14 Days