JowlsPhase 3NCT00510081
An Evaluation of an Injectable Material for Correction of Wrinkles
A Phase 3 study testing Calcium Hydroxylapatite injection in people with Jowls, run by Northwestern University.
Trial summary
The objective of this study is to determine the effectiveness of a filler in improving wrinkles. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Jowls
- What is being tested?
- Calcium Hydroxylapatite injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Feb 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-65
- Have wrinkles
- The subjects are in good health.
- The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Who cannot join
- Subjects who have received within the past 3 months or are planning to receive in the next 6 months, botulinum toxin injections for correction of wrinkles.
- Subjects who have received within the past one year any soft tissue augmentation material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level).
- Subjects with prior history of nodule formation or hypersensitivity reactions to lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite.
- Subjects who are currently using anticoagulation therapy.
- Subjects who have a history of bleeding disorders.
- Subjects who are unable to understand the protocol or to give informed consent.
- Subjects with mental illness.
About this study
Official title: An Open Label Evaluation of the Safety and Efficacy of Calcium Hydroxylapatite (Radiesse®) Injection in the Correction of Jowl-Associated Chin Notches
The objective of this study is to determine the effectiveness of a filler in improving wrinkles.
Read the detailed description
The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.
- Conditions
- Jowls
- Being tested
- Calcium Hydroxylapatite injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxylapatite injectionDevice
Also called Radiesse
filler injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | subjects will receive filler injections Receives: Device: Calcium Hydroxylapatite injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of wrinkles
Measured: 1 week
Secondary outcomes (1)
Development of adverse events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: The study was not executed. No subjects were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JowlsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University, Feinberg School of Medicine, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510081
- Sponsor's protocol ID
- 1253-013
- Status last verified
- Dec 2014
- First submitted
- 31 Jul 2007
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Evaluation of the Safety and Efficacy of Calcium Hydroxylapatite (Radiesse®) Injection in the Correction of Jowl-Associated Chin Notches
- ClinicalTrials.gov ID
- NCT00510081
- Acronym / sponsor ID
- 1253-013
- Conditions
- Jowls
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not executed. No subjects were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2009
- Study completion
- Feb 2009
- First posted
- 1 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the effectiveness of a filler in improving wrinkles.
Detailed description
The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Calcium Hydroxylapatite injectionsubjects will receive filler injections |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-65
- Have wrinkles
- The subjects are in good health.
- The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Key exclusion criteria (7 listed)
- Subjects who have received within the past 3 months or are planning to receive in the next 6 months, botulinum toxin injections for correction of wrinkles.
- Subjects who have received within the past one year any soft tissue augmentation material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level).
- Subjects with prior history of nodule formation or hypersensitivity reactions to lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite.
- Subjects who are currently using anticoagulation therapy.
- Subjects who have a history of bleeding disorders.
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 |
|---|---|---|
| Calcium Hydroxylapatite injectionAlso: Radiessefiller injection | Device | 1 |
Primary outcome
Correction of wrinkles
Time frame: 1 week
1 secondary outcome
Development of adverse events
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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.
Murad Alam, MD principal investigator
Northwestern University, Feinberg School of Medicine, Department of Dermatology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium Hydroxylapatite injection in people with Jowls, run by Northwestern University.
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 7 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: withdrawn, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Correction of wrinkles (time frame: 1 week). 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 9 Dec 2014.