Study to Evaluate Restylane Vital Light Using an Injector Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01412190
First received: June 30, 2011
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White administered with an injector device on aged skin in the face, hands and décolletage.


Condition Intervention
Aesthetics
Device: Restylane Vital Light
Other: No treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomized, Single-centre, Intra-individual Controlled, Explorative, Safety and Efficacy Study Comparing Restylane Vital White With no Treatment in the Face, Back of the Hands and décolletage, Using an Injector Device

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Elasticity [ Time Frame: 0,4,8,12,20,28,36 weeks ] [ Designated as safety issue: No ]
    To evaluate the change in elasticity from baseline for the treated and untreated side respectively.

  • GEIS subject [ Time Frame: 4,8,12,20,28,36 weeks ] [ Designated as safety issue: No ]
    To evaluate esthetic change from baseline as judged by the subjects using GEIS for the treated and untreated side respectively

  • GEIS blinded evaluator [ Time Frame: 12,20,28,36 weeks ] [ Designated as safety issue: No ]
    To evaluate esthetic change from baseline as judged by the blinded evaluator using GEIS for the treated and untreated side respectively,

  • Skin structure [ Time Frame: 0,4,8,12,20,28,36 weeks ] [ Designated as safety issue: No ]
    To evaluate the change in skin structure from baseline for the treated and untreated side respectively.

  • Subject satisfaction [ Time Frame: 0,12,20,28,36 weeks ] [ Designated as safety issue: No ]
    To evaluate subject satisfaction

  • Best skin quality by blinded live evaluation [ Time Frame: 12,20,28,36 weeks ] [ Designated as safety issue: No ]
    To evaluate best skin quality of treated and untreated side judged by a blinded live evaluation


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 0-36 weeks ] [ Designated as safety issue: Yes ]
    To evaluate the safety of Restylane Vital White during the whole study by collecting Adverse Events

  • Subject diary [ Time Frame: 2 weeks after each treatment ] [ Designated as safety issue: Yes ]
    To evaluate the acute safety profile, i.e. treatment procedure reactions by direct questioning to subjects in a diary used daily for 2 weeks after each injection.


Enrollment: 30
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Untreated Other: No treatment
One side of face, one hand and one side of the décolletage is left untreated as a control.
Other Name: No treatment
Active Comparator: Restylane Vital Light
Restylane Vital Light administered at 3 treatment sessions 4 weeks apart
Device: Restylane Vital Light
Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart.
Other Name: Restylane skinbooster

Detailed Description:

The objectives are to explore the safety and efficacy profile of Restylane Vital White administered with an injector device when one side of the face, one of the hands and one side of the décolletage is treated and the other side of the face, the other hand and the other side of the décolletage is left untreated. The face, the hands and the décolletage will be evaluated separately for both the efficacy and the safety parameters.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent obtained
  • Female subjects 40-65 years of age, inclusive.
  • Visible signs of skin aging in the face, hands and décolletage (e.g. reduced skin elasticity, reduced turgor, actinic elastosis, smaller and larger wrinkles) according to the Investigators opinion.
  • Subjects must be cooperative and willing to comply with the instructions and procedures.

Exclusion Criteria:

  • Extensively photo damaged and aged skin according to the Investigators opinion.
  • Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face, hands or décolletage.
  • History of or active collagenosis (e.g. systemic lupus, erythematosis, Rheumatic arthritis, skin or systemic sclerosis)
  • Previous hypersensitivity to hyaluronic acid.
  • Concomitant therapy with thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, within 2 weeks before the baseline visit.
  • History of cancerous or pre-cancerous lesions in the face, hands and décolletage.
  • Previous tissue augmenting therapy with non-permanent filler or treatment with botulinum toxin, aesthetic surgical therapy, laser treatment, mesotherapy, or any form of peeling in the face, hands or décolletage within 12 months prior to the baseline visit.
  • Use of injectable revitalization preparations (e.g. Hyal System®, Restylane Vital) within 12 months prior to the baseline visit.
  • Use of retinoic acid within 6 months prior to the baseline visit.
  • Previous or concomitant treatment with chemotherapy, immunosuppressive agents or corticoids.
  • History of treatment with permanent filling materials.
  • Pregnancy or breast feeding woman or woman of childbearing potential not practicing adequate contraception.
  • Participation in any other clinical study within 30 days prior to the baseline visit or plan to participate in another clinical study during this study period.
  • Unrealistic expectation with regard to the esthetic results of the treatment.
  • Planned or ongoing weight reduction program during the study.
  • Known history of drug or alcohol abuse within 6 months prior to the baseline visit.
  • Known hypersensitivity to one or more components of EMLA cream®.
  • Any medical condition that in the opinion of the Investigator makes the subject unsuitable for inclusion (e.g. severe chronic disease, malignancy, bleeding disorder, skin diseases etc).
  • Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects anticipated to be unreliable, unable to return for the follow-up visits, not likely to avoid other prohibited treatments or procedures or incapable of understanding the information or instructions.
  • Nicotine use during the study or stopped within 12 months before the baseline visit.
  • Study staff or close relative of study staff (e.g. parents, children, siblings and spouse).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412190

Locations
Germany
University of Hamburg
Hamburg, Germany, 20146
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Martina Kerscher, Professor University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01412190     History of Changes
Other Study ID Numbers: 31GR0803
Study First Received: June 30, 2011
Last Updated: November 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Q-Med AB:
Skin rejuvenation

ClinicalTrials.gov processed this record on July 22, 2014