Clinical trial NCT01428024: Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh
Official title: An Open, Multi-center Study Evaluating Efficacy, Safety and Injection Technique of Restylane Lip Products for Lip Enhancement and Lip Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Techniques
Keywords: efficacy
safety
Restylane
Lip products
injection techniques
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
timeFrame: At week 8 - change of lips from baseline
Secondary outcomes:
measure: GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment
timeFrame: week 36 - change from baseline
measure: GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment
timeFrame: week 36 - change from baseline
measure: GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment
timeFrame: week 36 - change from baseline
measure: MLFS (Medicis Lip Fullness Scale) at Week 8
timeFrame: week 8 - change from baseline
measure: Subject Satisfaction Questionnaire
timeFrame: Week 8
measure: Subject Diary for 14 Days After Initial Treatment
timeFrame: 2 weeks after initial treatment
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Göteborgs Plastikkirurgiska Center
city: Stockholm
country: Sweden
facility: Stureplanskliniken
city: Stockholm
country: Sweden
facility: Akademikliniken
Study officials:
affiliation: Akademikliniken, Storängsvägen 10, 115 42 Stockholm
name: Ulf Samuelsson, Med Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 Göteborg
name: Dan Fagrell, Med Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm
name: Pyra Haglund, Med Dr
role: PRINCIPAL_INVESTIGATOR
References: