Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3
Phase 4
Completed
- Conditions
- Nasolabial FoldsPhysiological StressDisorder of AgingSkin DiseasesWrinkles
- Interventions
- Device: Hyaluronic Acid Filler
- Registration Number
- NCT01305187
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hyaluronic Acid Filler - Medical Device Hyaluronic Acid Filler -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Global assessment of subject comfort at V3 by the investigator and the subject 2 Weeks Overall GAIS by photo rating of an individual rater V2 post implantation and V4 4 Weeks 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 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 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 Subject Satisfaction Questionnaire results at V4 4 Weeks Global assessment of subject comfort at V4 by the investigator and the subject 4 Weeks Subject Satisfaction Questionnaire results at V3 2 Weeks 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 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 Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4 4 Weeks Global assessment of subject comfort at V2 post implantation by the investigator and the subject. 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 Subject Satisfaction Questionnaire results at V2 pre and post implantation Week 0
Trial Locations
- Locations (1)
Praxisklinik Kaiserplatz
🇩🇪Frankfurt am Main, Germany