Clinical trial NCT01305187: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Physiological Stress
Disorder of Aging
Skin Diseases
Wrinkles
Nasolabial Folds
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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
timeFrame: Week 4
Secondary outcomes:
measure: Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
timeFrame: Week 0
measure: Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
timeFrame: 2 Weeks
measure: Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation
timeFrame: 4 Weeks
measure: 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
timeFrame: Week 0
measure: 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
timeFrame: 2 Weeks
measure: 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
timeFrame: 4 Weeks
measure: 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
timeFrame: 4 Weeks
measure: Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4
timeFrame: 4 Weeks
measure: Overall GAIS by photo rating of an individual rater V2 post implantation and V4
timeFrame: 4 Weeks
measure: Subject Satisfaction Questionnaire results at V2 pre and post implantation
timeFrame: Week 0
measure: Subject Satisfaction Questionnaire results at V3
timeFrame: 2 Weeks
measure: Subject Satisfaction Questionnaire results at V4
timeFrame: 4 Weeks
measure: Global assessment of subject comfort at V2 post implantation by the investigator and the subject.
timeFrame: Week 0
measure: Global assessment of subject comfort at V3 by the investigator and the subject
timeFrame: 2 Weeks
measure: Global assessment of subject comfort at V4 by the investigator and the subject
timeFrame: 4 Weeks
measure: Proportion of subjects feeling the implant at V2 post implantation
timeFrame: Week 0
measure: Proportion of subjects feeling the implant at V3.
timeFrame: 2 Weeks
measure: Proportion of subjects feeling the implant at V4
timeFrame: 4 Weeks
measure: Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Praxisklinik Kaiserplatz
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Clemens Acker, Dr.
role: STUDY_DIRECTOR
References: