A Phase 4 interventional study of Hyaluronic Acid Filler in Physiological Stress, Disorder of Aging and Skin Diseases, sponsored by Merz Pharmaceuticals GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-20.
Sponsored by Merz Pharmaceuticals GmbH (part of Merz Pharma) · Phase 4, Interventional, and Treatment
This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds
544 studies on the registry are indexed under Skin Diseases; 93 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 379 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →Merz Pharmaceuticals GmbH is the lead sponsor of 61 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
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
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
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
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
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
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
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
Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4
Time frame: 4 Weeks
Overall GAIS by photo rating of an individual rater V2 post implantation and V4
Time frame: 4 Weeks
Subject Satisfaction Questionnaire results at V2 pre and post implantation
Time frame: Week 0
Subject Satisfaction Questionnaire results at V3
Time frame: 2 Weeks
Subject Satisfaction Questionnaire results at V4
Time frame: 4 Weeks
Global assessment of subject comfort at V2 post implantation by the investigator and the subject.
Time frame: Week 0
Global assessment of subject comfort at V3 by the investigator and the subject
Time frame: 2 Weeks
Global assessment of subject comfort at V4 by the investigator and the subject
Time frame: 4 Weeks
Proportion of subjects feeling the implant at V2 post implantation
Time frame: Week 0
Proportion of subjects feeling the implant at V3.
Time frame: 2 Weeks
Proportion of subjects feeling the implant at V4
Time frame: 4 Weeks
Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4
Time frame: 4 Weeks
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.