Facial WrinklesNCT00922623
Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI
A study testing Belotero® in people with Facial Wrinkles, run by Merz North America, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- Belotero®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2009to Jul 2010
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
- Had used exclusionary medications/treatments.
- Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pearl E Grimes
Los Angeles, California, 90036
Valerie Callender
Mitchellville, Maryland, 20721
Jeanine B Downie
Montclair, New Jersey, 07042
About this study
Official title: 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.
Read the 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
- Being tested
- Belotero®
- Keywords
- Nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotero®Device
Also called Nasolabial folds
Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer
| Study group | Role | What they receive |
|---|---|---|
| Belotero® | Experimental | Not described Receives: Device: Belotero® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2010
- Study completionJul 2010
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 Facial WrinklesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rhoda Narins, MD, Principal investigator, Dermatology Surgery and Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922623
- Sponsor's protocol ID
- MUS 90028-0622/1 Supplement
- Status last verified
- Apr 2013
- First submitted
- 3 Jun 2009
- Last updated
- 26 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00922623
- Acronym / sponsor ID
- MUS 90028-0622/1 Supplement
- Conditions
- Facial Wrinkles
- Keywords
- Nasolabial folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Posted 30 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belotero® | Experimental | Device: Belotero® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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®Also: Nasolabial foldsHyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer | Device | Belotero® |
Primary outcome
Percentage of Subjects With Product-related Adverse Events.
Time frame: 24 weeks
Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- 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.
Rhoda Narins, MD principal investigator
Dermatology Surgery and Laser Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belotero® in people with Facial Wrinkles, run by Merz North America, Inc. at 3 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 6 inclusion and 12 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 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2012). 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?
Percentage of Subjects With Product-related Adverse Events. (time frame: 24 weeks). 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 26 Apr 2013.