CompletedNCT01529203FIRSTUpdated Feb 18, 2021Results posted

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

A Phase 3 interventional study of Botulinum Toxin Type A (Azzalure) and Restylane ranges in Aging, sponsored by Galderma R&D. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Galderma R&D · Phase 3, Interventional, and Other

Phase: Phase 3
Study type: Interventional
Enrollment: 60
Allocation: Not applicable
Ages: 18 Years to 64 Years
Sex: All

Study summary

The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.

This will be an open, multi-centre study.

Conditions studied

Aging

In context

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Main Inclusion Criteria:

Male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria

Main Exclusion Criteria:

Female subject who is pregnant, nursing or planning a pregnancy during the study
Subject with any contraindications to the injection of hyaluronic acid (see package inserts)
Subject with any contraindications to the injection of botulinum toxin (see package insert)
Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin
Concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments
Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations
Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit

Study design

Phase: Phase 3
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

Other
Azzalure and Restylane
All subjects will be injected with Azzalure and Restylane
Drug: Botulinum Toxin Type A (Azzalure) · Device: Restylane ranges

Interventions

DrugBotulinum Toxin Type A (Azzalure)
Powder for solution for injection
DeviceRestylane ranges
Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)

What researchers measure

Primary outcomes

Subject Satisfaction for the Full Face
based on the subject's satisfaction questionnaire
Time frame: Month 6

Secondary outcomes

Global Aesthetic Improvement From Baseline
The scale responses are: -1 indicating "worse", 0 indicating "no change", 1 indicating "improved", 2 indicating "much improved" and 3 indicating "very much improved".
Time frame: Week 3
Related Adverse Event
Number of subjects reporting related adverse events
Time frame: Month 6

Results

Posted Apr 25, 2014

Participant flow

Participant flow — Overall Study
Milestone	Azzalure and Restylane
Started	60
Completed	57
Not completed	3

Outcome measures

PrimarySubject Satisfaction for the Full Face

based on the subject's satisfaction questionnaire

Time frame:: Month 6
Reported as:: Number · percentage of total subjects

Subject Satisfaction for the Full Face
percentage of total subjects	Azzalure and Restylane
satisfied or very satisfied	92.9
neutral	7.1

SecondaryGlobal Aesthetic Improvement From Baseline

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

Time frame:: Week 3
Reported as:: Number · percentage of total subjects

Global Aesthetic Improvement From Baseline
percentage of total subjects	Azzalure and Restylane
Improved	0
Much or very much improved	100

SecondaryRelated Adverse Event

Number of subjects reporting related adverse events

Time frame:: Month 6
Reported as:: Number · participants

Related Adverse Event
participants	Azzalure and Restylane
Related Adverse Event	14

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Azzalure and Restylane	—	2/60 (3.3%)	18/60 (30%)

Most frequent serious events

Most frequent serious events
Event	Azzalure and Restylane
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/60
Cerebral infarctionNervous system disorders	1/60

Most frequent other events

Most frequent other events
Event	Azzalure and Restylane
Skin swellingSkin and subcutaneous tissue disorders	9/60
NasopharyngitisInfections and infestations	3/60
Injection site haematomaGeneral disorders	2/60
contusionInjury, poisoning and procedural complications	2/60
headacheNervous system disorders	2/60

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Azzalure and Restylane
Mean	47.6 ± 7.5

Age, Categorical
Age, Categorical(Participants)	Azzalure and Restylane
<=18 years	0
Between 18 and 65 years	60
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Azzalure and Restylane
Female	50
Male	10

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Azzalure and Restylane
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	60
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Azzalure and Restylane
France	20
Spain	20
United Kingdom	20

Study locations

5 sites

Galderma investigational site
Bordeaux, France
Galderma investigational site
Metz, France
Galderma investigational site
Madrid, Spain
Galderma investigational site
London, United Kingdom
Galderma investigational site
Street, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01529203
Lead sponsor: Galderma R&D
Responsible party: Sponsor
First posted: Feb 8, 2012
Start date: Feb 2012
Primary completion: Apr 2013
Completion: Apr 2013
Results posted: Apr 25, 2014
Last update: Feb 18, 2021

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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