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Completed

NCT Number: NCT01305187

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

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

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Key information

Conditions

Physiological Stress Disorder of Aging Nasolabial Folds Skin Diseases Skin and Connective Tissue Diseases Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Praxisklinik Kaiserplatz

Frankfurt am Main, 60311, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: Week 4

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4

    Time frame: 4 Weeks

  9. Overall GAIS by photo rating of an individual rater V2 post implantation and V4

    Time frame: 4 Weeks

  10. Subject Satisfaction Questionnaire results at V2 pre and post implantation

    Time frame: Week 0

  11. Subject Satisfaction Questionnaire results at V3

    Time frame: 2 Weeks

  12. Subject Satisfaction Questionnaire results at V4

    Time frame: 4 Weeks

  13. Global assessment of subject comfort at V2 post implantation by the investigator and the subject.

    Time frame: Week 0

  14. Global assessment of subject comfort at V3 by the investigator and the subject

    Time frame: 2 Weeks

  15. Global assessment of subject comfort at V4 by the investigator and the subject

    Time frame: 4 Weeks

  16. Proportion of subjects feeling the implant at V2 post implantation

    Time frame: Week 0

  17. Proportion of subjects feeling the implant at V3.

    Time frame: 2 Weeks

  18. Proportion of subjects feeling the implant at V4

    Time frame: 4 Weeks

  19. Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4

    Time frame: 4 Weeks

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2011
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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