A Randomised, Subject-blinded Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride 0.3%
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Facial Tissue Augmentation
- Sponsor
- Galderma R&D
- Enrollment
- 54
- Locations
- 3
- Primary Endpoint
- Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
The Restylane SubQ gel is intended to be used for facial tissue augmentation. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this split-face designed study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained with the dermal filler using the global esthetic improvement scale (GEIS).
Investigators
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.
Outcomes
Primary Outcomes
Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.
Time Frame: When injection of both cheeks were completed
When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).
Secondary Outcomes
- Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)(2 weeks)
- Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.(15 and 120 minutes)
- Number of Subjects Reporting Adverse Event(Up to 12 months)
- Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks(2 weeks)
- 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.(14 days)