A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride

Galderma R&D54 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Facial Tissue Augmentation

Interventions

Restylane SubQDEVICE

Treatment with up to 2 ml of the product

Restylane SubQ LidocaineDEVICE

Treatment with up to 2 ml of the product

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Plastikkirurggruppen

Stockholm, Sweden

ZMedical

Stockholm, Sweden

Akademikliniken

Stockholm, Sweden

Outcomes

Primary Outcomes

Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.

When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).

Time frame: When injection of both cheeks were completed

Secondary Outcomes

Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.

Pain was assessed during the first 2 hours after the initial injection of the study products using a 100 mm VAS. The endpoints of the scale were "no pain" (0 mm) and "worst possible pain" (100 mm). Pain was assessed at the time points 15, 30, 60, 90 and 120 minutes after injection.

Time frame: 15 and 120 minutes

Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)

Esthetic improvement was evaluated by using Global Esthetic Improvement Scale. GEIS was evaluated by comparing current photos with pre-treatment photos and using a 5-graded scale (worse/no change/somewhat improved/much improved/very much improved). A clinically significant global esthetic improvement was defined as a score of somewhat improved, much improved or very much improved. GEIS was assessed by the Investigator and the subject. Each cheek/study product was evaluated separately. GEIS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.

Time frame: 2 weeks

Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks

The severity of midface volume loss or midface contour deficiency was assessed by the investigators using a 4-graded scale, Medicis Midface Volume Scale -MMVS (1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing). Each score were exemplified by photographic images on the scale. A one grade decrease in score from screening was defined as a treatment success/improvement.The efficacy in terms of Medicis Midface Volume Scale (MMVS) was assessed by the Investigator per treatment group. The two cheeks were evaluated separately. MMVS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.

Data from ClinicalTrials.gov

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