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

NCT01529203 | Completed Phase 3 Results

• 1 other identifier: RD.03.SPR.29097
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 5

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Subject Satisfaction for the Full Face

  based on the subject's satisfaction questionnaire

  Month 6

Secondary Outcomes (2)

• Global Aesthetic Improvement From Baseline

  Week 3

• Related Adverse Event

  Month 6

Study Arms (1)

Azzalure and Restylane

OTHER

All subjects will be injected with Azzalure and Restylane

Drug: Botulinum Toxin Type A (Azzalure); Device: Restylane ranges

Interventions

Botulinum Toxin Type A (Azzalure) DRUG

Powder for solution for injection

Azzalure and Restylane

Restylane ranges DEVICE

Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)

Azzalure and Restylane

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (5)

Galderma investigational site

Bordeaux, France

Location

Galderma investigational site

Metz, France

Location

Galderma investigational site

Madrid, Spain

Location

Galderma investigational site

London, United Kingdom

Location

Galderma investigational site

Street, United Kingdom

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Galderma

may.ma@galderma.com

(33) 4 92 38 67 33

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 18, 2021
• Results First Posted: April 25, 2014

Record last verified: 2014-09

Locations

FR (2); ES (1); GB (2)