Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00876265
First received: April 3, 2009
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

This was a study to find out how an investigational product, Belotero, compares to a second product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face that go from the outside of the nostrils to the edges of the mouth. Additionally, this study determined Belotero is safe and tolerable and corrects facial wrinkles, such as nasolabial folds.


Condition Intervention Phase
Facial Wrinkles
Device: Belotero
Device: Zyplast
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Controlled, Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®, After Mid-to-Deep Dermal Implantation for Correction of Moderate to Severe Facial Wrinkles

Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Adjusted (LS) Mean Change From Baseline in Wrinkle Severity Rating Scale (SRS) Score of Each Nasolabial Fold (NLF) as Determined by the Blinded Evaluator at Week 12. [ Time Frame: Baseline and Week 12 of follow-up ] [ Designated as safety issue: No ]
    The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.


Enrollment: 118
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belotero Device: Belotero
Belotero, injectable hyaluronic acid gel device, implanted into the nasolabial fold in the Treatment Phase of the study (multiple injections of 0.1 to 0.2 mL, up to a maximum of 3 mL over 2 treatment sessions). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered.
Active Comparator: Zyplast Device: Zyplast
Zyplast Collagen Implant, an injectable dermal collagen device, implanted into the nasolabial fold in the Treatment Phase of the study (average injection of 1.0 mL). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered. Zyplast was obtained by each site from commercially available supplies.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects reviewed and signed a statement of Informed Consent and a HIPAA authorization prior to initiating any study-specific procedures. In addition, subjects were asked to provide a separate release for use of their photographs in publications. Subjects could refuse the photo release without jeopardizing their eligibility to participate in the study.
  2. Subjects were 18 - 75 years of age, and of any race or sex.
  3. Female subjects were postmenopausal for at least 1 year, had a hysterectomy, or had a tubal ligation; or, if of childbearing potential, agreed to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device [IUD], or spermicide in combination with a barrier method of contraception), were abstinent, or were in a monogamous relationship with a vasectomized partner; and had a negative urine pregnancy test at the screening visit.
  4. Subjects had bilateral nasolabial folds with a severity score of 2 or 3 on the wrinkle SRS assessed by the blinded evaluator.
  5. Each subject had an adequate understanding of the language (spoken and written English or Spanish) and was willing to comply with the study requirements.

Exclusion Criteria:

  1. A personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (eg, lidocaine, etc), HA preparations, and/or gram-positive bacterial protein.
  2. A known history of keloids or bleeding disorders.
  3. An active inflammatory process in the nasolabial fold area (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, psoriasis, neurodermatitis, or any other active skin disease) or severe scarring that might interfere with study assessments.
  4. Women who were pregnant, planning to become pregnant during the study, or who were breast-feeding.
  5. Subjects who planned to undergo major facial surgery during the course of the study (eg, rhinoplasty [with or without implant], facelift, congenital defect repair, etc).
  6. Subjects with clinically important disease, as judged by the investigator, within 3 months of the study (eg, significant laboratory test abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases [scleroderma, systemic lupus erythematous], systemic infection, uncontrolled diabetes, etc.), including those with medical conditions that might require the use of immunosuppressive medications during the trial (eg, severe, uncontrolled asthma, rheumatoid arthritis, autoimmune diseases, etc).
  7. Severe physical, neurological or mental disease.
  8. Excessive facial hair that might interfere with the evaluation of the wrinkle assessments.
  9. Any systemic or dermatologic disorder, which, in the opinion of the investigator,would interfere with the study results or increase the risk of adverse events (AEs).
  10. Subjects who had used exclusionary medications/treatments.
  11. Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876265

Locations
United States, Alabama
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
United States, California
Skin Care & Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Maas Clinic
San Francisco, California, United States, 94115
United States, Connecticut
Savin Dermatology
New Haven, Connecticut, United States, 06511
United States, Louisiana
William Coleman, III, MD
Metairie, Louisiana, United States, 70006
United States, New York
Dermatology Surgery and Laser Center
White Plains, New York, United States, 10604
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Rhoda Narins, MD Dermatology Surgery and Laser Center
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00876265     History of Changes
Other Study ID Numbers: MUS 90028-0622/1
Study First Received: April 3, 2009
Results First Received: December 13, 2011
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals, LLC:
Facial wrinkles
Nasolabial fold

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014