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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT02403986
First received: March 26, 2015
Last updated: May 8, 2017
Last verified: May 2017
  Purpose

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.

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.


Condition Intervention Phase
Aged Skin Device: Restylane Vital Skinboosters Lidocaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • To evaluate the aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 18 months after completed initial treatment regimen ]
  • To evaluate safety by collecting adverse events [ Time Frame: 18 months after completed initial treatment regimen ]

Estimated Enrollment: 50
Study Start Date: April 2015
Study Completion Date: March 30, 2017
Primary Completion Date: March 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02403986

Locations
Germany
Rosenpark Research
Darmstadt, Germany
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Gerhard Sattler, MD Rosenpark Research
Principal Investigator: Martina Kerscher, MD University of Hamburg
  More Information

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT02403986     History of Changes
Other Study ID Numbers: CTN 05DF1404
Study First Received: March 26, 2015
Last Updated: May 8, 2017

Additional relevant MeSH terms:
Lidocaine
Hyaluronic Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 19, 2017