Clinical trial NCT01412190: Study to Evaluate Restylane Vital Light Using an Injector Device
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aesthetics
Keywords: Skin rejuvenation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

Primary outcomes:
measure: Elasticity
timeFrame: 0,4,8,12,20,28,36 weeks
measure: GEIS subject
timeFrame: 4,8,12,20,28,36 weeks
measure: GEIS blinded evaluator
timeFrame: 12,20,28,36 weeks
measure: Skin structure
timeFrame: 0,4,8,12,20,28,36 weeks
measure: Subject satisfaction
timeFrame: 0,12,20,28,36 weeks
measure: Best skin quality by blinded live evaluation
timeFrame: 12,20,28,36 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 0-36 weeks
measure: Subject diary
timeFrame: 2 weeks after each treatment
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University of Hamburg
Study officials:
affiliation: University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg
name: Martina Kerscher, Professor
role: PRINCIPAL_INVESTIGATOR
References: