Trial Outcomes & Findings for Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles (NCT NCT01014871)

Last Updated: 2021-02-18

Results Overview

Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5

Results posted on

2021-02-18

Participant Flow

Recruitment process: patients from private practice - Recruitment period: First Patient In = 13 July 2009 Last Patient In = 09 November 2009 - Type of location: hospital

Participant milestones

Participant milestones
Measure	Vistabel/Azzalure at Baseline: * 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead * 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vistabel/Azzalure n=30 Participants at Baseline: * 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead * 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46.4 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Germany	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5

Population: Intention To Treat

Outcome measures

Adverse Events

Azzalure

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Vistabel

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Azzalure n=30 participants at risk intra-individual comparison	Vistabel n=30 participants at risk intra-individual comparison
Gastrointestinal disorders DENTAL DISCOMFORT	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Skin and subcutaneous tissue disorders EYELID OEDEMA	16.7% 5/30 • Number of events 5 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	16.7% 5/30 • Number of events 5 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Eye disorders EYELID PTOSIS	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Nervous system disorders FACIAL PARESIS	13.3% 4/30 • Number of events 4 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	13.3% 4/30 • Number of events 4 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Nervous system disorders HEADACHE	13.3% 4/30 • Number of events 4 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	16.7% 5/30 • Number of events 5 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
General disorders INJECTION SITE PARAESTHESIA	3.3% 1/30 • Number of events 1 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Infections and infestations NASOPHARYNGITIS	10.0% 3/30 • Number of events 3 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	10.0% 3/30 • Number of events 3 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Respiratory, thoracic and mediastinal disorders PHARYNGOLARYNGEAL PAIN	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Musculoskeletal and connective tissue disorders SENSATION OF HEAVINESS	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 2 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Nervous system disorders MIGRAINE	6.7% 2/30 • Number of events 3 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.	6.7% 2/30 • Number of events 3 • 5 months All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.

Additional Information

Florence Paliargues / CPM

Galderma

Phone: +33492952957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Disclosure agreement in full force and effect for a period of 10 years.
Publication restrictions are in place

Restriction type: OTHER

Measure	Azzalure n=30 Participants at Baseline: \- 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead	Vistabel n=30 Participants at Baseline: \- 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Baseline at rest	1.4 Scores on a scale Standard Deviation 0.5	1.4 Scores on a scale Standard Deviation 0.5
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 1 at rest	1.3 Scores on a scale Standard Deviation 0.5	1.3 Scores on a scale Standard Deviation 0.5
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 2 at rest	1.0 Scores on a scale Standard Deviation 0.6	1.0 Scores on a scale Standard Deviation 0.5
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 3 at rest	0.9 Scores on a scale Standard Deviation 0.6	0.8 Scores on a scale Standard Deviation 0.5
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 7 at rest	0.7 Scores on a scale Standard Deviation 0.7	0.7 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 10 at rest	0.5 Scores on a scale Standard Deviation 0.6	0.5 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 14 at rest	0.6 Scores on a scale Standard Deviation 0.6	0.5 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 30 at rest	0.6 Scores on a scale Standard Deviation 0.6	0.6 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Month 4 at rest	1.0 Scores on a scale Standard Deviation 0.5	1.0 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Month 5 at rest	1.2 Scores on a scale Standard Deviation 0.6	1.3 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Baseline at maximum contraction	2.1 Scores on a scale Standard Deviation 0.3	2.1 Scores on a scale Standard Deviation 0.3
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 1 at maximum contraction	1.8 Scores on a scale Standard Deviation 0.6	1.8 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 2 at maximum contraction	1.6 Scores on a scale Standard Deviation 0.6	1.5 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 3 at maximum contraction	1.2 Scores on a scale Standard Deviation 0.7	1.1 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 7 at maximum contraction	0.7 Scores on a scale Standard Deviation 0.7	0.7 Scores on a scale Standard Deviation 0.7
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 10 at maximum contraction	0.6 Scores on a scale Standard Deviation 0.7	0.6 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 14 at maximum contraction	0.5 Scores on a scale Standard Deviation 0.6	0.4 Scores on a scale Standard Deviation 0.5
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Month 4 at maximum contraction	1.5 Scores on a scale Standard Deviation 0.5	1.4 Scores on a scale Standard Deviation 0.6
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Month 5 at maximum contraction	1.8 Scores on a scale Standard Deviation 0.6	1.9 Scores on a scale Standard Deviation 0.5
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead Day 30 at maximum contraction	0.5 Scores on a scale Standard Deviation 0.6	0.5 Scores on a scale Standard Deviation 0.5