Trial Outcomes & Findings for Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines (NCT NCT00856414)

NCT ID: NCT00856414

Last Updated: 2019-01-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

14 Days

Results posted on

2019-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Botulinum Toxin Type A 20U botulinum toxin Type A 20U
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Type A 20U n=45 Participants botulinum toxin Type A 20U
Age, Continuous	43.5 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 Days

Population: Intent to Treat defined as all patients who started the study

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A 20U n=45 Participants botulinum toxin Type A 20U
The First Visit Onset of Efficacy as Measured by Physician Assessment	2.2 Number of Days Standard Deviation 0.55

PRIMARY outcome

Timeframe: 14 Days

Population: Intent to Treat defined as all patients who started the study

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A 20U n=45 Participants botulinum toxin Type A 20U
The First Visit Onset of Efficacy as Measured by Subject Assessment	1.84 Number of Days Standard Deviation 1.01

SECONDARY outcome

Timeframe: 14 Days

Population: Intent to Treat defined as all patients who started the study

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A 20U n=45 Participants botulinum toxin Type A 20U
Average Subject Assessment Score in Improvement of Appearance of Frown Lines 1st Diary Week	1.73 Scores on a Scale Standard Deviation 0.65
Average Subject Assessment Score in Improvement of Appearance of Frown Lines 2nd Diary Week	2.64 Scores on a Scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: Intent to Treat defined as all patients who started the study

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A 20U n=45 Participants botulinum toxin Type A 20U
Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score Baseline	32.97 Scores on a Scale Standard Deviation 19.91
Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score Change from Baseline at Day 14	38.55 Scores on a Scale Standard Deviation 28.20

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: Intent to Treat defined as all patients who started the study

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A 20U n=45 Participants botulinum toxin Type A 20U
Percentage of Patients Reporting Self-Perception of Age (SPA) Baseline Looking Younger	22.2 Percentage of patients
Percentage of Patients Reporting Self-Perception of Age (SPA) Baseline Looking Current Age	40.0 Percentage of patients
Percentage of Patients Reporting Self-Perception of Age (SPA) Baseline Looking Older	37.8 Percentage of patients
Percentage of Patients Reporting Self-Perception of Age (SPA) Day 14 Looking Younger	42.2 Percentage of patients
Percentage of Patients Reporting Self-Perception of Age (SPA) Day 14 Looking Current Age	44.4 Percentage of patients
Percentage of Patients Reporting Self-Perception of Age (SPA) Day 14 Looking Older	13.3 Percentage of patients

Adverse Events

Botulinum Toxin Type A 20U

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President, Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER