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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01305187
First received: February 25, 2011
Last updated: June 17, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Physiological Stress
Disorder of Aging
Skin Diseases
Wrinkles
Nasolabial Folds
Device: Hyaluronic Acid Filler
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Overall GAIS by photo rating of an individual rater V2 post implantation and V4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Subject Satisfaction Questionnaire results at V2 pre and post implantation [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Subject Satisfaction Questionnaire results at V3 [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Subject Satisfaction Questionnaire results at V4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Global assessment of subject comfort at V2 post implantation by the investigator and the subject. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Global assessment of subject comfort at V3 by the investigator and the subject [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Global assessment of subject comfort at V4 by the investigator and the subject [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects feeling the implant at V2 post implantation [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Proportion of subjects feeling the implant at V3. [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects feeling the implant at V4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT01305187

Locations
Germany
Praxisklinik Kaiserplatz
Frankfurt am Main, Germany, 60311
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Director: Clemens Acker, Dr. Merz Pharmaceuticals GmbH
  More Information

No publications provided

Responsible Party: Dr. Matthias Zerm, Manager Public Disclosure, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01305187     History of Changes
Other Study ID Numbers: MRZ 90028_4007_0
Study First Received: February 25, 2011
Last Updated: June 17, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Skin Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014