Nasolabial FoldsPhase 4NCT01635855
Belotero Post Approval Study
A Phase 4 study testing Belotero® in people with Nasolabial Folds, run by Merz North America, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Belotero®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2012to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 16Show fewer
- 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.
- All Fitzpatrick skin types are eligible for study participation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Birmingham, Alabama
Study site
Glenn Dale, Maryland
Study site
Los Angeles, California, 90069
Study site
Los Angeles, California
Study site
Metairie, Louisiana
Study site
Montclair, New Jersey
Study site
New Haven, Connecticut
Study site
San Francisco, California
Study site
White Plains, New York
About this study
Official title: Belotero® Post Approval Study for the Treatment of Nasolabial Folds
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
- Being tested
- Belotero®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotero®Device
Hyaluronic acid dermal filler
| Study group | Role | What they receive |
|---|---|---|
| Belotero | Experimental | Belotero® Hyaluronic acid dermal filler Receives: Device: Belotero® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635855
- Sponsor's protocol ID
- P110637
- Status last verified
- Jul 2014
- First submitted
- 5 Jul 2012
- Last updated
- 4 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belotero® Post Approval Study for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT01635855
- Acronym / sponsor ID
- P110637
- Conditions
- Nasolabial Folds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 4 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belotero | Experimental | Device: Belotero®Belotero® Hyaluronic acid dermal filler |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belotero®Hyaluronic acid dermal filler | Device | Belotero |
Primary outcome
Rate of Severe Common Adverse Events
Time frame: 1 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belotero® in people with Nasolabial Folds, run by Merz North America, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Severe Common Adverse Events (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2014.