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

NCT00922623 | Completed Results

• 1 other identifier: MUS 90028-0622/1 Supplement
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

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.

Conditions

Facial Wrinkles

Keywords

Nasolabial folds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Belotero®

EXPERIMENTAL

Device: Belotero®

Interventions

Belotero® DEVICE

Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer

Also known as: Nasolabial folds

Belotero®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Was 18 to 75 years of age, of any race or sex.
• 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.
• Had bilateral nasolabial folds with a severity of 2 or 3 on the wrinkle severity rating scale (SRS) as assessed by the Evaluator Investigator.
• Subjects were to have been rated IV, V, or VI on the Fitzpatrick Skin Phototype Scale.
• Had adequate understanding of the language (spoken and written English or Spanish) and was willing to comply with the study requirements.

You may not qualify if:

• 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.
• A known history of keloids or bleeding disorders.
• Leukoderma (vitiligo) or a family history of leukoderma or other pigmentary disorders.
• 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.
• If female, pregnant, planning to become pregnant during the study, or breast feeding.
• Planned to undergo major facial surgery during the course of the study (eg, rhinoplasty \[with or without implant\], facelift, congenital defect repair, etc).
• 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).
• Severe physical, neurological or mental disease.
• Excessive facial hair that might interfere with the evaluation of the wrinkle assessments.
• Any systemic or dermatologic disorder, which, in the opinion of the investigator, would interfere with the study results or increase the risk of AEs.
• Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (3)

Pearl E Grimes

Los Angeles, California, 90036, United States

Location

Valerie Callender

Mitchellville, Maryland, 20721, United States

Location

Jeanine B Downie

Montclair, New Jersey, 07042, United States

Location

Results Point of Contact

• Title: Merz Aesthetics, Inc.
• Organization: Merz Aesthetics, Inc.

clinicaltrials@merzaesthetics.com

650-286-4000

Study Officials

• Rhoda Narins, MD

  Dermatology Surgery and Laser Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 17, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 26, 2013
• Results First Posted: January 30, 2012

Record last verified: 2013-04

Locations

US (3)