Back to resultsNon-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3
Primary Purpose
Physiological Stress, Disorder of Aging, Skin Diseases
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Hyaluronic Acid Filler
Sponsored by
About this trial
This is an interventional treatment trial for Physiological Stress
Eligibility Criteria
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
Sites / Locations
- Praxisklinik Kaiserplatz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyaluronic Acid Filler - Medical Device
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
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
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
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
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
Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4
Overall GAIS by photo rating of an individual rater V2 post implantation and V4
Subject Satisfaction Questionnaire results at V2 pre and post implantation
Subject Satisfaction Questionnaire results at V3
Subject Satisfaction Questionnaire results at V4
Global assessment of subject comfort at V2 post implantation by the investigator and the subject.
Global assessment of subject comfort at V3 by the investigator and the subject
Global assessment of subject comfort at V4 by the investigator and the subject
Proportion of subjects feeling the implant at V2 post implantation
Proportion of subjects feeling the implant at V3.
Proportion of subjects feeling the implant at V4
Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4
Full Information
NCT ID
NCT01305187
First Posted
February 25, 2011
Last Updated
June 17, 2011
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01305187
Brief Title
Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiological Stress, Disorder of Aging, Skin Diseases, Wrinkles, Nasolabial Folds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic Acid Filler - Medical Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hyaluronic Acid Filler
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
Time Frame
Week 0
Title
Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
Time Frame
2 Weeks
Title
Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
Time Frame
4 Weeks
Title
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
Time Frame
Week 0
Title
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
Time Frame
2 Weeks
Title
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
Time Frame
4 Weeks
Title
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
Time Frame
4 Weeks
Title
Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4
Time Frame
4 Weeks
Title
Overall GAIS by photo rating of an individual rater V2 post implantation and V4
Time Frame
4 Weeks
Title
Subject Satisfaction Questionnaire results at V2 pre and post implantation
Time Frame
Week 0
Title
Subject Satisfaction Questionnaire results at V3
Time Frame
2 Weeks
Title
Subject Satisfaction Questionnaire results at V4
Time Frame
4 Weeks
Title
Global assessment of subject comfort at V2 post implantation by the investigator and the subject.
Time Frame
Week 0
Title
Global assessment of subject comfort at V3 by the investigator and the subject
Time Frame
2 Weeks
Title
Global assessment of subject comfort at V4 by the investigator and the subject
Time Frame
4 Weeks
Title
Proportion of subjects feeling the implant at V2 post implantation
Time Frame
Week 0
Title
Proportion of subjects feeling the implant at V3.
Time Frame
2 Weeks
Title
Proportion of subjects feeling the implant at V4
Time Frame
4 Weeks
Title
Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens Acker, Dr.
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Praxisklinik Kaiserplatz
City
Frankfurt am Main
ZIP/Postal Code
60311
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3
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