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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01428024
First received: August 31, 2011
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Injection Techniques
Device: Restylane Lip Volume
Device: Restylane Lip Refresh

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Multi-center Study Evaluating Efficacy, Safety and Injection Technique of Restylane Lip Products for Lip Enhancement and Lip Rejuvenation

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • GEIS (Global Esthetic Improvement Scale)subject [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS


Secondary Outcome Measures:
  • GEIS subject [ Time Frame: week 2, 4, 12, 26 and 36 ] [ Designated as safety issue: No ]
    To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS

  • GEIS by treating investigator [ Time Frame: week 2, 4, 8, 12, 26 and 36 ] [ Designated as safety issue: No ]
    To evaluate esthetic change of lips from baseline as judged by the treating investigator using GEIS

  • GEIS by independent evaluator [ Time Frame: week 2, 4, 8, 12, 26 and 36 ] [ Designated as safety issue: No ]
    To evaluate esthetic change of lips from baseline as judged by independent evaluator using GEIS

  • MLFS (Medicis Lip Fullness Scale) [ Time Frame: week 0, 2, 4, 8, 12, 26 and 36 ] [ Designated as safety issue: No ]
    To evaluate the efficacy in terms of Medicis Lip Fullness Scale (MLFS) score by live assessment performed by the treating and the independent investigators in the Restylane Lip Volume group.

  • Subject satisfaction questionnaire [ Time Frame: 0, 2, 4, 8, 12, 26 and 36 ] [ Designated as safety issue: No ]
    To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire

  • Injection satisfaction questionnaire [ Time Frame: week 0,2,12,36 ] [ Designated as safety issue: No ]
    To evaluate injection technique and ease of injection in terms of a treating investigator questionnaire

  • Subject diary [ Time Frame: 2 weeks after first treatment ] [ Designated as safety issue: Yes ]
    To evaluate the acute safety profile in terms of a 14-day subject diary after initial treatment

  • Adverse Events [ Time Frame: 0-36 weeks ] [ Designated as safety issue: Yes ]
    To evaluate long-term safety throughout the study period


Enrollment: 60
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Restylane LipVolume and Restylane Lip Refresh
Open label
Device: Restylane Lip Volume
Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and week 12.
Device: Restylane Lip Refresh
Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and week 12.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428024

Locations
Sweden
Göteborgs Plastikkirurgiska Center
Göteborg, Sweden, 412 65
Akademikliniken
Stockholm, Sweden, 115 42
Stureplanskliniken
Stockholm, Sweden, 111 44
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Ulf Samuelsson, Med Dr Akademikliniken, Storängsvägen 10, 115 42 Stockholm
Principal Investigator: Dan Fagrell, Med Dr Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 Göteborg
Principal Investigator: Pyra Haglund, Med Dr Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01428024     History of Changes
Other Study ID Numbers: 31GE1102
Study First Received: August 31, 2011
Last Updated: November 22, 2012
Health Authority: Sweden: The regional ethics commitée in Stockholm

Keywords provided by Q-Med AB:
efficacy
safety
Restylane
Lip products
injection techniques

ClinicalTrials.gov processed this record on April 17, 2014