Study to Evaluate Restylane Vital Light Using an Injector Device

NCT01412190 | Completed

• 1 other identifier: 31GR0803
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aesthetics

Keywords

Skin rejuvenation

Outcome Measures

Primary Outcomes (6)

• Elasticity

  To evaluate the change in elasticity from baseline for the treated and untreated side respectively.

  0,4,8,12,20,28,36 weeks

• GEIS subject

  To evaluate esthetic change from baseline as judged by the subjects using GEIS for the treated and untreated side respectively

  4,8,12,20,28,36 weeks

• GEIS blinded evaluator

  To evaluate esthetic change from baseline as judged by the blinded evaluator using GEIS for the treated and untreated side respectively,

  12,20,28,36 weeks

• Skin structure

  To evaluate the change in skin structure from baseline for the treated and untreated side respectively.

  0,4,8,12,20,28,36 weeks

• Subject satisfaction

  To evaluate subject satisfaction

  0,12,20,28,36 weeks

• Best skin quality by blinded live evaluation

  To evaluate best skin quality of treated and untreated side judged by a blinded live evaluation

  12,20,28,36 weeks

Secondary Outcomes (2)

• Adverse Events

  0-36 weeks

• Subject diary

  2 weeks after each treatment

Study Arms (2)

Untreated

OTHER

Other: No treatment

Restylane Vital Light

ACTIVE COMPARATOR

Restylane Vital Light administered at 3 treatment sessions 4 weeks apart

Device: Restylane Vital Light

Interventions

Restylane Vital Light DEVICE

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.

Also known as: Restylane skinbooster

Restylane Vital Light

No treatment OTHER

One side of face, one hand and one side of the décolletage is left untreated as a control.

Untreated

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

University of Hamburg

Hamburg, 20146, Germany

Location

Study Officials

• Martina Kerscher, Professor

  University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: August 9, 2011
• Study Start: April 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 25, 2022

Record last verified: 2012-11

Locations

DE (1)