Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3

Monocentric, Randomized, Subject and Rater Blinded Clinical Investigation to Prove the Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3 Containing Lidocaine - After Single Injection for Correction of Nasolabial Folds (NLF)

This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Wrinkles; Physiological Stress; Nasolabial Folds; Disorder of Aging
• Intervention / Treatment: Device: Hyaluronic Acid Filler

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60311
    • Praxisklinik Kaiserplatz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject with bilateral, symmetrical NLF and wish for correction. Documented severity of NLF score 2 or 3 at screening on the Merz Wrinkle Severity Rating Scale II

Exclusion Criteria:

• Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal). Subject suffering from diabetes mellitus, autoimmune and rheumatic diseases, clinically relevant coagulation disorders, recurrent angina, or severe psychic, neurological or mental disease
• History of malignancy within the last 5 years before the study
• Infection, inflammations or active dermatological disease in the face

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hyaluronic Acid Filler - Medical Device

Device: Hyaluronic Acid Filler; The dosage is individualized depending on the depth of the NLF. The goal is to achieve optimal correction of both NLF with single implantations of Belotero® Basic and Juvéderm® Ultra 3 respectively. Each subject will be injected with Belotero® Basic and Lidocaine containing Juvéderm® Ultra 3 according to a split-face design. The allocation of fillers to the side of the face will be randomized. The randomization method is block-wise with a ratio 1:1 to the groups Belotero® Basic left and Juvéderm® Ultra 3 right, Belotero® Basic right and Juvéderm® Ultra 3 left.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects reporting an equal or better outcome for the side of face treated with Belotero® Basic compared to the side of face treated with Juvéderm® Ultra 3 at V4 on the validated Wrinkle Severity Rating Scale II	Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation	Week 0
Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation	2 Weeks
Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation	4 Weeks
Overall absolute score change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater	Week 0
Overall absolute score change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater	2 Weeks
Overall absolute score change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater	4 Weeks
Proportion of overall responders i.e. at least 1 point improvement in the validated Wrinkle Severity Rating Scale II(WSRS II) at V4, based on the intra-individual change in WSRS II compared to baseline before implantation, V2 pre implantation	4 Weeks
Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4	4 Weeks
Overall GAIS by photo rating of an individual rater V2 post implantation and V4	4 Weeks
Subject Satisfaction Questionnaire results at V2 pre and post implantation	Week 0
Subject Satisfaction Questionnaire results at V3	2 Weeks
Subject Satisfaction Questionnaire results at V4	4 Weeks
Global assessment of subject comfort at V2 post implantation by the investigator and the subject.	Week 0
Global assessment of subject comfort at V3 by the investigator and the subject	2 Weeks
Global assessment of subject comfort at V4 by the investigator and the subject	4 Weeks
Proportion of subjects feeling the implant at V2 post implantation	Week 0
Proportion of subjects feeling the implant at V3.	2 Weeks
Proportion of subjects feeling the implant at V4	4 Weeks
Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4	4 Weeks

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH
• Investigators: Study Director: Clemens Acker, Dr., Merz Pharmaceuticals GmbH

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): June 20, 2011
• Last Update Submitted That Met QC Criteria: June 17, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: MRZ 90028_4007_0