Trial Outcomes & Findings for Subject Satisfaction With AbobutulinumtoxinA Treatment (NCT NCT03687736)

NCT ID: NCT03687736

Last Updated: 2022-08-26

Results Overview

Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-08-26

Participant Flow

Participant milestones

Measure	abobotulinumtoxinA open-label AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region
Overall Study STARTED	120
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	abobotulinumtoxinA open-label AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Subject Satisfaction With AbobutulinumtoxinA Treatment

Baseline characteristics by cohort

Measure	AbobotulinumtoxinA n=120 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	120 Participants n=5 Participants
Toxin Naive Status Toxin Naive	39 Participants n=5 Participants
Toxin Naive Status Non-toxin Naive	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Modified Intent to Treat Population (all subjects treated with study product both at Baseline and Month 6) attending Month 12 visit.

Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.

Outcome measures

Measure	AbobotulinumtoxinA n=110 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines Highly satisfied	66 Participants
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines Satisfied	38 Participants
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines Dissatisfied	4 Participants
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines Highly dissatisfied	2 Participants

SECONDARY outcome

Timeframe: Months 1,3,6,7,9 and 12

Population: Intent to Treat population (all subjects treated with study product). Number analyzed = Number of subjects completing Subject Satisfaction questionnaire at each visit following treatment.

based on Subject Satisfaction questionnaire data

Outcome measures

Measure	AbobotulinumtoxinA n=117 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 1 · Very satisfied	83 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 1 · Satisfied	32 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 1 · Dissatisfied	2 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 1 · Very dissatisfied	0 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 3 · Very satisfied	44 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 3 · Satisfied	55 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 3 · Dissatisfied	14 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 3 · Very dissatisfied	2 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 6 · Very satisfied	35 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 6 · Satisfied	50 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 6 · Dissatisfied	23 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 6 · Very dissatisfied	5 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 7 · Very satisfied	78 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 7 · Satisfied	26 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 7 · Dissatisfied	2 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 7 · Very dissatisfied	0 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 9 · Very satisfied	61 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 9 · Satisfied	40 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 9 · Dissatisfied	8 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 9 · Very dissatisfied	2 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 12 · Very satisfied	43 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 12 · Satisfied	49 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 12 · Dissatisfied	16 Participants
Subject Satisfaction With Aesthetic Outcome in Treated Area Month 12 · Very dissatisfied	2 Participants

SECONDARY outcome

Timeframe: Months 1,3,6,7,9 and 12

Population: Intent to Treat Population (all subjects treated with study product) attending visit.

FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.

Outcome measures

Measure	AbobotulinumtoxinA n=120 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows Baseline	31.6 score on a scale Standard Deviation 18.22
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows Month 1	83.3 score on a scale Standard Deviation 19.22
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows Month 3	64.2 score on a scale Standard Deviation 22.46
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows Month 6	44.7 score on a scale Standard Deviation 20.78
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows Month 7	85.5 score on a scale Standard Deviation 17.77
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows Month 9	70.7 score on a scale Standard Deviation 23.23
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows Month 12	51.5 score on a scale Standard Deviation 22.18

SECONDARY outcome

Timeframe: Months 1,3,6,7,9 and 12

Population: Intent to Treat Population (all subjects treated with study product) attending visit.

FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.

Outcome measures

Measure	AbobotulinumtoxinA n=120 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Evaluate the Impact of Treatment; Psychological Function Baseline	72.2 score on a scale Standard Deviation 22.56
Evaluate the Impact of Treatment; Psychological Function Month 1	84.0 score on a scale Standard Deviation 15.94
Evaluate the Impact of Treatment; Psychological Function Month 3	81.6 score on a scale Standard Deviation 17.29
Evaluate the Impact of Treatment; Psychological Function Month 6	78.0 score on a scale Standard Deviation 20.35
Evaluate the Impact of Treatment; Psychological Function Month 7	85.1 score on a scale Standard Deviation 17.60
Evaluate the Impact of Treatment; Psychological Function Month 9	82.7 score on a scale Standard Deviation 19.02
Evaluate the Impact of Treatment; Psychological Function Month 12	79.0 score on a scale Standard Deviation 17.46

SECONDARY outcome

Timeframe: Months 1,3,6,7,9 and 12

Population: Intent to Treat Population (all subjects treated with study product) attending visit.

Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown

Outcome measures

Measure	AbobotulinumtoxinA n=120 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Subject Self-Assessment Using a 4-point Categorical Scale Baseline · Severe	78 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Baseline · Moderate	42 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Baseline · Mild	0 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Baseline · None	0 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 1 · Severe	0 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 1 · Moderate	10 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 1 · Mild	54 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 1 · None	53 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 3 · Severe	12 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 3 · Moderate	50 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 3 · Mild	45 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 3 · None	8 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 6 · Severe	55 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 6 · Moderate	48 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 6 · Mild	10 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 6 · None	0 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 7 · Severe	0 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 7 · Moderate	14 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 7 · Mild	36 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 7 · None	56 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 9 · Severe	9 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 9 · Moderate	31 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 9 · Mild	53 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 9 · None	18 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 12 · Severe	34 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 12 · Moderate	57 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 12 · Mild	19 Participants
Subject Self-Assessment Using a 4-point Categorical Scale Month 12 · None	0 Participants

SECONDARY outcome

Timeframe: Months 1,3,6,7,9 and 12

Population: Intent to Treat Population (all subjects treated with study product) attending visit.

Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.

Outcome measures

Measure	AbobotulinumtoxinA n=120 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Baseline · Severe	82 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Baseline · Moderate	38 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Baseline · Mild	0 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Baseline · None	0 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 1 · Severe	0 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 1 · Moderate	2 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 1 · Mild	24 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 1 · None	91 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 3 · Severe	8 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 3 · Moderate	27 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 3 · Mild	57 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 3 · None	23 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 6 · Severe	50 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 6 · Moderate	47 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 6 · Mild	16 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 6 · None	0 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 7 · Severe	0 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 7 · Moderate	3 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 7 · Mild	22 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 7 · None	81 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 9 · Severe	2 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 9 · Moderate	30 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 9 · Mild	45 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 9 · None	34 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 12 · Severe	35 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 12 · Moderate	57 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 12 · Mild	16 Participants
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity Month 12 · None	2 Participants

SECONDARY outcome

Timeframe: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit

Population: Intent to Treat Population (all subjects treated with study product) who returned diary cards.

Subject perception of treatment response

Outcome measures

Measure	AbobotulinumtoxinA n=116 Participants Open-label AbobotulinumtoxinA: abobotulinumtoxinA treatment in the glabellar region
Onset of Treatment Response Following Baseline Treatment	2.5 days Standard Error 0.14
Onset of Treatment Response Following Month 6 Treatment	2.4 days Standard Error 0.12

Adverse Events

AbobotulinumtoxinA

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	AbobotulinumtoxinA n=120 participants at risk Open-label AbobotulinumtoxinA: AbobotulinumtoxinA treatment in the glabellar region
Surgical and medical procedures Abdominoplasty	0.83% 1/120 • Number of events 1 • 12 months
Gastrointestinal disorders Intra-abdominal haemorrhage	0.83% 1/120 • Number of events 1 • 12 months
Renal and urinary disorders Ureterolithiasis	0.83% 1/120 • Number of events 1 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Clinical Project Manager

Q-Med AB

Phone: (817) 961-5000

Email: aestheticclinicaltrials@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
• Publication restrictions are in place

Restriction type: OTHER