Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh

Galderma

Status: Completed

Conditions: Injection Techniques

Treatments: Device: Restylane Lip Refresh; Device: Restylane Lip Volume

Study type: Interventional

Funder types: Industry

Identifiers

NCT01428024

31GE1102

Details and patient eligibility

About

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.

Full description

Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is intended to restore hydrobalance and improve skin structure of the lips (referred to as lip rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this open, multicenter study are to evaluate efficacy and safety of the products for the studied indications and to collect information on injection techniques used.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Restylane Lip Volume

Experimental group

Description:

Submucosal injections with Restylane Lip Volume. Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 12.

Treatment:

Device: Restylane Lip Volume

Restylane Lip Refresh

Experimental group

Description:

Submucosal injections with Restylane Lip Refresh. Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 12.

Treatment:

Device: Restylane Lip Refresh