Clinical trial NCT01431755: A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride
Official title: A Randomised, Subject-blinded Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride 0.3%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Tissue Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.
timeFrame: When injection of both cheeks were completed
Secondary outcomes:
measure: Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.
timeFrame: 15 and 120 minutes
measure: Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)
timeFrame: 2 weeks
measure: Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks
timeFrame: 2 weeks
measure: 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.
timeFrame: 14 days
measure: Number of Subjects Reporting Adverse Event
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Plastikkirurggruppen
city: Stockholm
country: Sweden
facility: ZMedical
city: Stockholm
country: Sweden
facility: Akademikliniken
Study officials:
affiliation: Akademikliniken, Storängsvägen 10, 115 42 Stockholm
name: Per Hedén, M.D.
role: PRINCIPAL_INVESTIGATOR
References: