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

Skin Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305187
• Other study ID #: MRZ 90028_4007_0
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2011
• Last updated: June 17, 2011
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Disorder of Aging
• Nasolabial Folds
• Physiological Stress
• Skin Diseases
• Wrinkles

Intervention

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.

Locations

Country	Name	City	State
Germany	Praxisklinik Kaiserplatz	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation		Week 0	No
Secondary	Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation		2 Weeks	No
Secondary	Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation		4 Weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4		4 Weeks	No
Secondary	Overall GAIS by photo rating of an individual rater V2 post implantation and V4		4 Weeks	No
Secondary	Subject Satisfaction Questionnaire results at V2 pre and post implantation		Week 0	No
Secondary	Subject Satisfaction Questionnaire results at V3		2 Weeks	No
Secondary	Subject Satisfaction Questionnaire results at V4		4 Weeks	No
Secondary	Global assessment of subject comfort at V2 post implantation by the investigator and the subject.		Week 0	No
Secondary	Global assessment of subject comfort at V3 by the investigator and the subject		2 Weeks	No
Secondary	Global assessment of subject comfort at V4 by the investigator and the subject		4 Weeks	No
Secondary	Proportion of subjects feeling the implant at V2 post implantation		Week 0	No
Secondary	Proportion of subjects feeling the implant at V3.		2 Weeks	No
Secondary	Proportion of subjects feeling the implant at V4		4 Weeks	No
Secondary	Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4		4 Weeks	No