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

Galderma

Status and phase

Completed

Phase 3

Conditions

Aging

Treatments

Drug: Botulinum Toxin Type A (Azzalure)

Device: Restylane ranges

Study type

Interventional

Funder types

Industry

Identifiers

NCT01529203

RD.03.SPR.29097

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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