Belotero Post Approval Study

NCT01635855 | Completed Phase 4 Results

• 1 other identifier: P110637
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 9

Brief Summary

A prospective, open-label 1-month post-approval study to evaluate the short term safety of Belotero® Balance in the re-treatment of nasolabial folds.

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Rate of Severe Common Adverse Events

  The purpose of this study was to determine if the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies)."Common" is defined as pre-specified adverse events occurring in \>= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.

  1 month

Study Arms (1)

Belotero

EXPERIMENTAL

Belotero® Hyaluronic acid dermal filler

Device: Belotero®

Interventions

Belotero® DEVICE

Hyaluronic acid dermal filler

Belotero

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Was a participant in the Belotero® Balance pre-market IDE clinical trial or the Belotero Balance Fitzpatrick Skin Type IV-VI Study.
• Is a candidate for bilateral nasolabial fold re-treatment with Belotero® Balance.
• Understands and accepts the obligation not to receive any other facial procedures from enrollment through 1 month from optimal correction in the current study.
• Understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements.

You may not qualify if:

• Has received surgery in either nasolabial fold.
• Has received within the past 6 months a non-permanent filler (e.g. hyaluronic acid, CaHA) or neurotoxin below the zygomatic arch.
• Has received at any time a permanent filler (e.g. polylactic acid, PMMA, silicone) below the zygomatic arch.
• Has received within the past 6 months dermal resurfacing procedures (e.g. medium/deep chemical peel, dermabrasion treatments, ablative laser resurfacing) or non-invasive skin-tightening (e.g. Thermage) below the zygomatic arch.
• Has received in the past 2 weeks prescription facial wrinkle therapies (e.g., RENOVA®), topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) below the zygomatic arch.
• Has received in the past 2 months or plans to receive during the study immunosuppressive medications or systemic steroids (intranasal / inhaled steroids acceptable).
• Has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
• Has a known bleeding disorder or is using medication that reduces blood coagulation, (e.g. aspirin, non-steroidal anti-inflammatory drugs, or warfarin) which may increase the risk of bleeding during the treatment session.
• Has a known history of severe allergies manifested by a history of anaphylaxis; or history or presence of multiple severe allergies.
• Has known allergy or hypersensitivity to hyaluronic acid preparations, gram positive bacterial proteins or Belotero® or Belotero® derivative.
• Has a known history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
• Is a female of childbearing potential (e.g. not post-menopausal for at least one year or has not had a hysterectomy or tubal ligation) and is pregnant, lactating or plans to become pregnant during the study or is not using medically effective birth control.
• Has any other medical condition with the potential to interfere with the study or increase the risk of adverse events.
• Is enrolled or plans to enroll in a competitive or interfering study.
• Is an employee or direct relative of an employee of the investigational site or study sponsor.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (9)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Los Angeles, California, 90069, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Metairie, Louisiana, United States

Location

Unknown Facility

Glenn Dale, Maryland, United States

Location

Unknown Facility

Montclair, New Jersey, United States

Location

Unknown Facility

White Plains, New York, United States

Location

Results Point of Contact

• Title: Merz Pharmaceuticals North America
• Organization: Merz Pharmaceuticals North America

clinicaltrials@merzusa.com

800-334-0514

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-07

Locations

US (9)