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

Phase 3

Completed

• Conditions: Aging
• Interventions: Drug: Botulinum Toxin Type A (Azzalure); Device: Restylane ranges

• Registration Number: NCT01529203
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-30
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-03-24
• Results First Submitted QC: 2014-03-24
• Results First Posted: 2014-04-25
• Status Verified: 2014-09
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azzalure and Restylane	Botulinum Toxin Type A (Azzalure)	All subjects will be injected with Azzalure and Restylane
Azzalure and Restylane	Restylane ranges	All subjects will be injected with Azzalure and Restylane

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Global Aesthetic Improvement From Baseline	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".
Related Adverse Event	Month 6	Number of subjects reporting related adverse events

Trial Locations

Locations (1)

Galderma investigational site; 🇬🇧 Street, United Kingdom