NCT01529203CompletedPhase 3
Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Subject Satisfaction for the Full Face
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Azzalure and Restylane
Other
All subjects will be injected with Azzalure and Restylane
Intervention: Botulinum Toxin Type A (Azzalure) (Drug)
Azzalure and Restylane
Other
All subjects will be injected with Azzalure and Restylane
Intervention: Restylane ranges (Device)
Outcomes
Primary Outcomes
Subject Satisfaction for the Full Face
Time Frame: Month 6
based on the subject's satisfaction questionnaire
Secondary Outcomes
- Global Aesthetic Improvement From Baseline(Week 3)
- Related Adverse Event(Month 6)
Investigators
Study Sites (1)
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