Nasolabial FoldsPhase 4NCT01012388
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
A Phase 4 study testing Radiesse® Injectable Dermal Filler in people with Nasolabial Folds, run by Merz North America, Inc. at 5 sites in United States.
Trial summary
Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Radiesse® Injectable Dermal Filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2007to Feb 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age.
- Has Fitzpatrick Skin Type IV, V, or VI.
- Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.
Who cannot join
- Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
- Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
- Has nasolabial folds that are too severe to be corrected in one treatment session.
- Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
- Is pregnant, lactating, or not using acceptable contraception.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Chevy Chase, Maryland
Study site
Los Angeles, California
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
Ypsilanti, Michigan
About this study
Official title: Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler
- Conditions
- Nasolabial Folds
- Being tested
- Radiesse® Injectable Dermal Filler
- Keywords
- Moderate to severe wrinkles and folds such as nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse® Injectable Dermal FillerDevice
Calcium hydroxylapatite particles suspected in an aqueous based gel carrier
| Study group | Role | What they receive |
|---|---|---|
| Radiesse | Experimental | Not described Receives: Device: Radiesse® Injectable Dermal Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
Measured: 3 months
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionFeb 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 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
- NCT01012388
- Sponsor's protocol ID
- P1206248
- Status last verified
- Apr 2013
- First submitted
- 11 Nov 2009
- Last updated
- 26 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JY. Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI. Dermatol Surg. 2009 Oct;35 Suppl 2:1641-5. doi: 10.1111/j.1524-4725.2009.01311.x. Epub 2009 Aug 25.
PubMed 19708876
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
- Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
- ClinicalTrials.gov ID
- NCT01012388
- Acronym / sponsor ID
- P1206248
- Conditions
- Nasolabial Folds
- Keywords
- Moderate to severe wrinkles and folds such as nasolabial folds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 23 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiesse | Experimental | Device: Radiesse® Injectable Dermal Filler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least 18 years of age.
- Has Fitzpatrick Skin Type IV, V, or VI.
- Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.
Key exclusion criteria (5 listed)
- Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
- Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
- Has nasolabial folds that are too severe to be corrected in one treatment session.
- Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
- Is pregnant, lactating, or not using acceptable contraception.
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 |
|---|---|---|
| Radiesse® Injectable Dermal FillerCalcium hydroxylapatite particles suspected in an aqueous based gel carrier | Device | Radiesse |
Primary outcome
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
Time frame: 3 months
Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
Time frame: 6 months
Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
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.
- Results publication: PubMed 19708876Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JY. Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI. Dermatol Surg. 2009 Oct;35 Suppl 2:1641-5. doi: 10.1111/j.1524-4725.2009.01311.x. Epub 2009 Aug 25.
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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.
5 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 Radiesse® Injectable Dermal Filler in people with Nasolabial Folds, run by Merz North America, Inc. at 5 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 3 inclusion and 5 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 5 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 23 Dec 2009). 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?
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01012388, which also lists 1 linked publication.
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.