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

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.

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.

Study Overview

• Status: Completed
• Conditions: Facial Wrinkles
• Intervention / Treatment: Device: Belotero®

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
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • Pearl E Grimes
  • Maryland
    • Mitchellville, Maryland, United States, 20721
      • Valerie Callender
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Jeanine B Downie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Belotero®	Device: Belotero®; Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer; Other Names: Nasolabial folds

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (ESTIMATE): June 17, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 26, 2013
• Last Update Submitted That Met QC Criteria: April 19, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Nasolabial folds
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: MUS 90028-0622/1 Supplement