Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922623
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : January 30, 2012
Last Update Posted : April 26, 2013
Information provided by (Responsible Party):
Merz North America, Inc.

Brief Summary:
This is a study to assess how safe and effective an investigational product, Belotero® is in people with all skin types with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face that go from outside of the nostrils to the edges of the mouth.

Condition or disease Intervention/treatment Phase
Facial Wrinkles Device: Belotero® Not Applicable

Detailed Description:
The Fitzpatrick Skin Phototype Scale goes from number 1 (I), which is the very lightest skin tone, to number 6 (VI) which is the very darkest skin tone. This study is to determine the safety and effectiveness of Belotero® in people with skin phototypes of 1(I)thru 6 (VI).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 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 (Such as Nasolabial Folds) Over 24 Weeks in Subjects With Fitzpatrick Phototype Scores of IV, V, and VI.
Study Start Date : May 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: Belotero® Device: Belotero®
Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer
Other Name: Nasolabial folds

Primary Outcome Measures :
  1. Percentage of Subjects With Product-related Adverse Events. [ Time Frame: 24 weeks ]
    Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Had reviewed and signed a statement of Informed Consent and HIPAA authorization. In addition, subjects were asked to provide a separate release for use of their photographs in publications. Subjects had a right to refuse the photo release without jeopardizing their eligibility to participate in the study.
  2. Was 18 to 75 years of age, of any race or sex.
  3. If female, was post-menopausal for at least one year; or had undergone a hysterectomy; or a tubal ligation; or if of childbearing potential, had negative urine pregnancy test results and agreed to use an approved method of birth control throughout the study (ie, oral/systemic contraceptives, intrauterine device [IUD], or spermicide in combination with a barrier method of contraception), or was abstinent, or was in a monogamous relationship with a partner who had had a vasectomy.
  4. Had bilateral nasolabial folds with a severity of 2 or 3 on the wrinkle severity rating scale (SRS) as assessed by the Evaluator Investigator.
  5. Subjects were to have been rated IV, V, or VI on the Fitzpatrick Skin Phototype Scale.
  6. Had 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), hyaluronic acid (HA) preparations, and/or gram-positive bacterial protein.
  2. A known history of keloids or bleeding disorders.
  3. Leukoderma (vitiligo) or a family history of leukoderma or other pigmentary disorders.
  4. 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.
  5. If female, pregnant, planning to become pregnant during the study, or breast feeding.
  6. Planned to undergo major facial surgery during the course of the study (eg, rhinoplasty [with or without implant], facelift, congenital defect repair, etc).
  7. 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).
  8. Severe physical, neurological or mental disease.
  9. Excessive facial hair that might interfere with the evaluation of the wrinkle assessments.
  10. Any systemic or dermatologic disorder, which, in the opinion of the investigator, would interfere with the study results or increase the risk of AEs.
  11. Had used exclusionary medications/treatments.
  12. Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922623

United States, California
Pearl E Grimes
Los Angeles, California, United States, 90036
United States, Maryland
Valerie Callender
Mitchellville, Maryland, United States, 20721
United States, New Jersey
Jeanine B Downie
Montclair, New Jersey, United States, 07042
Sponsors and Collaborators
Merz North America, Inc.
Principal Investigator: Rhoda Narins, MD Dermatology Surgery and Laser Center

Responsible Party: Merz North America, Inc. Identifier: NCT00922623     History of Changes
Other Study ID Numbers: MUS 90028-0622/1 Supplement
First Posted: June 17, 2009    Key Record Dates
Results First Posted: January 30, 2012
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Merz North America, Inc.:
Nasolabial folds