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

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ClinicalTrials.gov Identifier: NCT01529203
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : April 25, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Aging Drug: Botulinum Toxin Type A (Azzalure) Device: Restylane ranges Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Study Start Date : February 2012
Primary Completion Date : April 2013
Study Completion Date : April 2013
Arms and Interventions

Arm Intervention/treatment
Azzalure and Restylane
All subjects will be injected with Azzalure and Restylane
Drug: Botulinum Toxin Type A (Azzalure)
Powder for solution for injection
Device: 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)


Outcome Measures

Primary Outcome Measures :
  1. Subject Satisfaction for the Full Face [ Time Frame: Month 6 ]
    based on the subject's satisfaction questionnaire


Secondary Outcome Measures :
  1. Global Aesthetic Improvement From Baseline [ Time Frame: 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".

  2. Related Adverse Event [ Time Frame: Month 6 ]
    Number of subjects reporting related adverse events


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529203


Locations
France
Galderma investigational site
Bordeaux, France
Galderma investigational site
Metz, France
Spain
Galderma investigational site
Madrid, Spain
United Kingdom
Galderma investigational site
London, United Kingdom
Galderma investigational site
Street, United Kingdom
Sponsors and Collaborators
Galderma
More Information

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01529203     History of Changes
Other Study ID Numbers: RD.03.SPR.29097
First Posted: February 8, 2012    Key Record Dates
Results First Posted: April 25, 2014
Last Update Posted: September 29, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Hyaluronic Acid
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents