N/A
N=60
Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh
Injection Techniques
Bottom Line
View on ClinicalTrials.gov: NCT01428024 ↗Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Oct 2018
Primary outcome: Primary: GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment — 86.2; 86.7 percentage improved subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Lip Volume (Device); Restylane Lip Refresh (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment |
86.2; 86.7 | — |
| SECONDARY GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment |
93.1; 78.6 | — |
| SECONDARY GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment |
82.8; 82.8 | — |
| SECONDARY GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment |
86.2; 86.2 | — |
| SECONDARY MLFS (Medicis Lip Fullness Scale) at Week 8 |
50.0 | — |
| SECONDARY Subject Satisfaction Questionnaire |
93; 87 | — |
| SECONDARY Subject Diary for 14 Days After Initial Treatment |
2; 6 | — |
Summary
The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.
Eligibility Criteria
Inclusion Criteria
- 18 to 60 years of age.
- Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
- Signed informed consent.
Exclusion Criteria
- Prior surgery or tattoo to the upper or lower lip or lip line.
- Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry.
- A history of herpes labialis and an outbreak within four weeks of study entry or with four or more outbreaks in the 12 months prior to study entry.
- Presence of facial hair that may interfere with efficacy evaluations.
- Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
- History of angioedema.
- Previous hypersensitivity to hyaluronic acid or local anesthetics.
- Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
- Cancerous or pre-cancerous lesions in the area to be treated.
- Previous tissue augmenting therapy in the area to be treated with hyaluronic acid (HA) or collagen filler, or laser treatment, during the last 12 months.
- Permanent implant placed in the area to be treated or treatment with non-HA or non-collagen filler in the area to be treated.
- Pregnancy or breast feeding.
- Participation in any other clinical study within 30 days prior to inclusion.
- Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the lower orbital rim, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
- Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).
Data sourced from ClinicalTrials.gov (NCT01428024). 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.