Facial VolumeNCT01565915
Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit
A study testing Perlane-L and Non-treatment in people with Facial Volume, run by Medicis Global Service Corporation at 11 sites in United States.
Trial summary
The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facial Volume
- What is being tested?
- Perlane-L and Non-treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2012to Dec 2013
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Loss of Fullness in Midface Area
- Other items as identified in the protocol
Who cannot join
- History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine.
- Other items as identified in the protocol
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Aventura, Florida
Study site
Beverly Hills, California
Study site
Chestnut Hill, Massachusetts
Study site
Chicago, Illinois
Study site
Coral Gables, Florida
Study site
Eugene, Oregon
Study site
Hunt Valley, Maryland
Study site
Mount Kisco, New York
Study site
New York, New York
Study site
San Francisco, California
Study site
Vista, California
About this study
The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.
- Conditions
- Facial Volume
- Being tested
- Perlane-L, Non-treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perlane-LDevice
Perlane-L Injection in the midface
Non-treatmentOther
Non-treatment Arm
| Study group | Role | What they receive |
|---|---|---|
| Perlane-L | Experimental | Perlane-L treatment Receives: Device: Perlane-L |
| Non-Treatment | Sham comparator | Non-Treatment Arm Receives: Other: Non-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial fullness using midface scale
Change in facial fullness using midface scale.
Measured: Week 8
Secondary outcomes (3)
Facial fullness using the midface scale
Change in facial fullness using midface scale.
Measured: Up to 12-months post treatment
Subject satisfaction using the GAIS
Compare treatment satisfaction as compared to no treatment, on the Global Aesthetic Improvement Scale (GAIS)
Measured: Up to 12-months post treatment
Aesthetic improvement
A subjective assessment of aesthetic improvement post baseline
Measured: Up to 12-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial VolumeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565915
- Sponsor's protocol ID
- MA-1400-05
- Status last verified
- Aug 2013
- First submitted
- 12 Mar 2012
- Last updated
- 21 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit
- ClinicalTrials.gov ID
- NCT01565915
- Acronym / sponsor ID
- MA-1400-05
- Conditions
- Facial Volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Mar 2012 (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 purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perlane-L | Experimental | Device: Perlane-LPerlane-L treatment |
| Non-Treatment | Sham comparator | Other: Non-treatmentNon-Treatment Arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Loss of Fullness in Midface Area
- Other items as identified in the protocol
Key exclusion criteria (2 listed)
- History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine.
- Other items as identified in the protocol
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 |
|---|---|---|
| Perlane-LPerlane-L Injection in the midface | Device | Perlane-L |
| Non-treatmentNon-treatment Arm | Other | Non-Treatment |
Primary outcome
Facial fullness using midface scale
Time frame: Week 8
Change in facial fullness using midface scale.
3 secondary outcomes
Facial fullness using the midface scale
Time frame: Up to 12-months post treatment
Subject satisfaction using the GAIS
Time frame: Up to 12-months post treatment
Aesthetic improvement
Time frame: Up to 12-months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perlane-L and Non-treatment in people with Facial Volume, run by Medicis Global Service Corporation at 11 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Facial fullness using midface scale (time frame: Week 8). 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 21 Aug 2013.