Trial Outcomes & Findings for Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range (NCT NCT01529203)

NCT ID: NCT01529203

Last Updated: 2021-02-18

Results Overview

based on the subject's satisfaction questionnaire

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	Azzalure and Restylane All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Overall Study STARTED	60
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range

Baseline characteristics by cohort

Measure	Azzalure and Restylane n=60 Participants All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Age, Continuous	47.6 years STANDARD_DEVIATION 7.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment France	20 participants n=5 Participants
Region of Enrollment Spain	20 participants n=5 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis

based on the subject's satisfaction questionnaire

Outcome measures

Measure	Azzalure and Restylane n=56 Participants All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Subject Satisfaction for the Full Face satisfied or very satisfied	92.9 percentage of total subjects
Subject Satisfaction for the Full Face neutral	7.1 percentage of total subjects

SECONDARY outcome

Timeframe: Week 3

The scale responses are: -1 indicating "worse", 0 indicating "no change", 1 indicating "improved", 2 indicating "much improved" and 3 indicating "very much improved".

Outcome measures

Measure	Azzalure and Restylane n=60 Participants All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Global Aesthetic Improvement From Baseline Improved	0 percentage of total subjects
Global Aesthetic Improvement From Baseline Much or very much improved	100 percentage of total subjects

SECONDARY outcome

Timeframe: Month 6

Number of subjects reporting related adverse events

Outcome measures

Measure	Azzalure and Restylane n=60 Participants All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Related Adverse Event	14 participants

Adverse Events

Azzalure and Restylane

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Azzalure and Restylane n=60 participants at risk All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.7% 1/60
Nervous system disorders Cerebral infarction	1.7% 1/60

Other adverse events

Measure	Azzalure and Restylane n=60 participants at risk All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
General disorders Injection site haematoma	3.3% 2/60
Infections and infestations Nasopharyngitis	5.0% 3/60
Injury, poisoning and procedural complications contusion	3.3% 2/60
Nervous system disorders headache	3.3% 2/60
Skin and subcutaneous tissue disorders Skin swelling	15.0% 9/60

Additional Information

Clinical Project Manager

Galderma

Phone: (33) 4 92 38 67 33

Email: may.ma@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60