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

NCT ID: NCT01428024

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-06-30

Brief Summary

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.

Detailed 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.

Conditions

Injection Techniques

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Restylane Lip Volume

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.

Group Type: EXPERIMENTAL

Restylane Lip Volume

Intervention Type: DEVICE

Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Restylane Lip Refresh

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.

Group Type: EXPERIMENTAL

Restylane Lip Refresh

Intervention Type: DEVICE

Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Interventions

Restylane Lip Volume

Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Intervention Type: DEVICE

Restylane Lip Refresh

Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulf Samuelsson, Med Dr

Role: PRINCIPAL_INVESTIGATOR

Akademikliniken, Storängsvägen 10, 115 42 Stockholm

Dan Fagrell, Med Dr

Role: PRINCIPAL_INVESTIGATOR

Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 Göteborg

Pyra Haglund, Med Dr

Role: PRINCIPAL_INVESTIGATOR

Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm

Locations

Göteborgs Plastikkirurgiska Center

Gothenburg, , Sweden

Stureplanskliniken

Stockholm, , Sweden

Akademikliniken

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

31GE1102

Identifier Type: -

Identifier Source: org_study_id