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

NCT02403986 | Completed Phase 4 Results

• 1 other identifier: CTN 05DF1404
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged Skin

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

R. Vital Skinboosters Lidocaine (three)

EXPERIMENTAL

Treatment with three initial sessions

Device: Restylane Vital Skinboosters Lidocaine

R. Vital Skinboosters Lidocaine (two)

EXPERIMENTAL

Treatment with two initial sessions

Device: Restylane Vital Skinboosters Lidocaine

Interventions

Restylane Vital Skinboosters Lidocaine DEVICE

R. Vital Skinboosters Lidocaine (three); R. Vital Skinboosters Lidocaine (two)

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Rosenpark Research

Darmstadt, Germany

Location

Results Point of Contact

• Title: Cecilia Skoglund, Manager Study strategy and publications
• Organization: Q-Med AB

cecilia.skoglund@galderma.com

46 18 474 9000

Study Officials

• Gerhard Sattler, MD

  Rosenpark Research

  PRINCIPAL INVESTIGATOR

• Martina Kerscher, MD

  University of Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: April 1, 2015
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: August 26, 2022
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Locations

DE (1)