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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01529203
First received: January 30, 2012
Last updated: September 16, 2014
Last verified: September 2014
  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:


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

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


Enrollment: 60
Study Start Date: February 2012
Study Completion Date: April 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 24, 2014
Last Updated: September 16, 2014
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
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014