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

NCT ID: NCT00922623

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-07-31

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.

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).

Conditions

Facial Wrinkles

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Belotero®

Group Type: EXPERIMENTAL

Belotero®

Intervention Type: DEVICE

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

Interventions

Belotero®

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

Intervention Type: DEVICE

Other Intervention Names

Nasolabial folds

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhoda Narins, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Surgery and Laser Center

Locations

Pearl E Grimes

Los Angeles, California, United States

Valerie Callender

Mitchellville, Maryland, United States

Jeanine B Downie

Montclair, New Jersey, United States

Countries

United States

Other Identifiers

MUS 90028-0622/1 Supplement

Identifier Type: -

Identifier Source: org_study_id