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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01529203
First received: January 30, 2012
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Aging
 Drug: Botulinum Toxin Type A (Azzalure)
Device: Restylane ranges
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:
  • Subject satisfaction for the full face [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    based on the subject's satisfaction questionnaire


Secondary Outcome Measures:
  • Global aesthetic improvement from baseline [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Scale from -1(worse) to 3 (very much improved)

  • Related Adverse Event [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
    Number of subjects reporting related adverse events


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01529203     History of Changes
Other Study ID Numbers: RD.03.SPR.29097
Study First Received: January 30, 2012
Last Updated: November 7, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013