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OpenTrials
Completed

NCT Number: NCT01529203

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

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.

Completed

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Key information

Conditions

Aging

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma investigational site, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A (Azzalure)

Drug

Powder for solution for injection

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)

Primary outcomes

  1. Subject Satisfaction for the Full Face

    Time frame: Month 6

    based on the subject's satisfaction questionnaire

Secondary outcomes

  1. Global Aesthetic Improvement From Baseline

    Time frame: 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".

  2. Related Adverse Event

    Time frame: Month 6

    Number of subjects reporting related adverse events

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Acronym: FIRST

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 8, 2012
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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