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

Aging Clinical Trial

— FIRST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529203
• Other study ID #: RD.03.SPR.29097
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: September 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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)

Locations

Country	Name	City	State
France	Galderma investigational site	Bordeaux
France	Galderma investigational site	Metz
Spain	Galderma investigational site	Madrid
United Kingdom	Galderma investigational site	London
United Kingdom	Galderma investigational site	Street

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Satisfaction for the Full Face	based on the subject's satisfaction questionnaire	Month 6
Secondary	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".	Week 3
Secondary	Related Adverse Event	Number of subjects reporting related adverse events	Month 6