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

NCT01305187 | Completed Phase 4

• 1 other identifier: MRZ 90028_4007_0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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

Study Arms (1)

Hyaluronic Acid Filler - Medical Device

EXPERIMENTAL

Device: Hyaluronic Acid Filler

Interventions

Hyaluronic Acid Filler DEVICE

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.

Hyaluronic Acid Filler - Medical Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

Praxisklinik Kaiserplatz

Frankfurt am Main, 60311, Germany

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Clemens Acker, Dr.

  Merz Pharmaceuticals GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 20, 2011

Record last verified: 2011-06

Locations

DE (1)