Phase 3
Completed N=60
Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Source: ClinicalTrials.gov NCT01529203 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Apr 2014
Primary outcomePrimary: Subject Satisfaction for the Full Face — 92.9; 7.1 percentage of total subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Satisfaction for the Full Face |
92.9; 7.1 | — |
| SECONDARY Global Aesthetic Improvement From Baseline |
0; 100 | — |
| SECONDARY Related Adverse Event |
14 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01529203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.