N/A
N=54
A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride
Facial Tissue Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT01431755 ↗Enrolled (actual)
54
Serious AEs
2.5%
Results posted
Apr 2014
Primary outcome: Primary: Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful. — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane SubQ (Device); Restylane SubQ Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful. |
100 | — |
| SECONDARY Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment. |
28.4; 2.9; 7.3; 1.3 | — |
| SECONDARY Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS) |
90.7; 96.3; 92.6; 100.0 | — |
| SECONDARY Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks |
55.6; 59.3 | — |
| SECONDARY Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment. |
54; 52 | — |
| SECONDARY Number of Subjects Reporting Adverse Event |
41 | — |
Summary
The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- Intent to undergo contouring of both cheeks with 1.5 to 2 ml Restylane SubQ per cheek.
- Sufficient symmetry of the face in order to ensure similar volume to be injected, similar injection technique and time for injection.
- Signed informed consent.
Exclusion Criteria
- Surgery in the midface including aesthetic facial surgical therapy, sinus surgery or dental root surgery within the past 12 months.
- Chronic infection in head and neck region.
- Ongoing infections in mouth.
- Tendency for edema, puffiness or swelling over the zygomatic prominence.
- Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
- 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 non-permanent filler, laser treatment, or chemical peeling during the last 6 months.
- Permanent implant placed in the area to be treated.
- Reduced sensibility in the facial region e.g. due to trauma, facial pareses, previous tissue augmenting therapy, aesthetic facial surgical therapy, laser treatment, or peeling.
- 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 upper orbital rim, subjects anticipated to be unreliable or incapable of understanding the VAS assessment, insufficient tissue support or cover of the treatment area.
Data sourced from ClinicalTrials.gov (NCT01431755). 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.