An Efficacy and Safety Study Evaluating Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face

A Randomised, Multi-centre, Parallel-group, Efficacy and Safety Study Evaluating Two and Three Initial Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face

A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.

Study Overview

• Status: Completed
• Conditions: Aged Skin
• Intervention / Treatment: Device: Restylane Vital Skinboosters Lidocaine

Detailed Description

Approximately 50 female subjects shall be treated with two or three initial treatment sessions including long-term follow-up 18 months after the initial treatment regimen. Efficacy and safety to be evaluated.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Darmstadt, Germany
    • Rosenpark Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Provision of signed and dated informed consent to participate in the study.
• Non-pregnant, non-breast feeding female aged 35-45 years.
• Visible signs of aging in the face
• Intent to improve skin hydration, skin structure and the elasticity of the skin using - Restylane Skinboosters Vital Lidocaine.

Exclusion Criteria:

• Extensively photo damaged and aged skin.
• Woman who plan to become pregnant during the course of the study.
• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
• Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
• History of severe or multiple allergies manifested by anaphylaxis.
• History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation, Omega-3 or Vitamin E within 10 days before study treatment
• Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three months before study treatment.
• Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the face.
• Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler, neurotoxin or revitalisation preparations (e.g. Hyal System or Restylane Skinboosters) in the face within 12 months before study treatment.
• Previous tissue revitalisation treatment with laser or light, radiofrequency, focused ultrasound, chemical peeling, dermabrasion, mesotherapy or any other similar treatment with influence on skin quality in the face within 6 months before study treatment.
• Previous aesthetic facial surgical therapy, liposuction or tattoo in the face.
• Previous sinus surgery or dental root surgery within 3 months before study treatment.
• Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne, psoriasis or herpes zoster in the face.
• History of or active collagen diseases or autoimmune diseases such as systemic lupus erythematosus, rheumatic arthritis, skin or systemic sclerosis.
• Tendency to form keloids, hypertrophic scars or any other healing disorder.
• History of radiation of or cancerous or pre-cancerous lesions (e.g. actinic keratosis) in the face.
• Use of systemic or facial topical retinoic acid within 12 months before study treatment.
• Nicotine use within 6 months before study treatment. (Occasional smoking, such as 1-5 cigarettes per week, or similar amount of nicotine, is allowed).
• Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. chronic, relapsing or hereditary disease that may interfere with the outcome of the study.
• Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial aesthetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
• Study site personnel or close relatives of the study site personnel (e.g. parents, children, siblings and spouse) or employees at the Sponsor company.
• Participation in any other clinical study within 3 months before study treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R. Vital Skinboosters Lidocaine (three); Treatment with three initial sessions	Device: Restylane Vital Skinboosters Lidocaine
Experimental: R. Vital Skinboosters Lidocaine (two); Treatment with two initial sessions	Device: Restylane Vital Skinboosters Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject	Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.	Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator	Investigator assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.	Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Gerhard Sattler, MD, Rosenpark Research; Principal Investigator: Martina Kerscher, MD, University of Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: CTN 05DF1404