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

NCT ID: NCT02403986

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-03-30

Brief Summary

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.

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.

Conditions

Aged Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R. Vital Skinboosters Lidocaine (three)

Treatment with three initial sessions

Group Type: EXPERIMENTAL

Restylane Vital Skinboosters Lidocaine

Intervention Type: DEVICE

R. Vital Skinboosters Lidocaine (two)

Treatment with two initial sessions

Group Type: EXPERIMENTAL

Restylane Vital Skinboosters Lidocaine

Intervention Type: DEVICE

Interventions

Restylane Vital Skinboosters Lidocaine

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Sattler, MD

Role: PRINCIPAL_INVESTIGATOR

Rosenpark Research

Martina Kerscher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hamburg-Eppendorf

Locations

Rosenpark Research

Darmstadt, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CTN 05DF1404

Identifier Type: -

Identifier Source: org_study_id