Forehead WrinklesNCT01950065
Effectiveness and Safety Study of the Iovera Device for the Temporary Reduction in the Appearance of Forehead Wrinkles
A study testing iovera in people with Forehead Wrinkles, run by Pacira Pharmaceuticals, Inc at 6 sites in United States.
Trial summary
Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the appearance of forehead wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Forehead Wrinkles
- What is being tested?
- iovera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2013to Oct 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Subject has a forehead wrinkle rating by the Investigator/designee of at least "2" in full contraction on the 5-point Wrinkle Scale (5WS) as rated by the study Investigator, which, upon physical manipulation/separation of the skin, demonstrates a reduction in wrinkle severity
- Subject has a glabella wrinkle rating by the Investigator/designee of at least "1" in full contraction on the 5-point Glabella Scale (5GS)
- Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5-point Wrinkle Scale (5WS) as rated by the Investigator/designee
- Subject has Fitzpatrick Skin Type I, II, III, or IV (see Error! Reference source not found.)
- Subject understands and commits to comply with study requirements
- Subject is in good general health and free of any condition that could impair either complete study participation or evaluation of forehead wrinkle rating
- Subject is willing and able to give written informed consent
Who cannot join
- Subject has a clotting disorder or coagulopathy that requires regular use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidogrel, etc.)
- Subject has used aspirin or any non-steroidal anti-inflammatory drugs (NSAIDs) within seven (7) days prior to screening or use of the device
- Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
- Subject has undergone another surgical cosmetic procedure or botulinum toxin injection at or above the level of the zygoma (cheekbones) within the past six (6) months prior to screening
- Subject has a resting wrinkle score of "3" or higher on the 5WS as rated by the study Investigator
- Subject actively elevates forehead during rest
Show all 24Show fewer
- Subject has been treated with any fillers listed in Error! Reference source not found. in the temple or forehead area in the time intervals specified prior to screening
- Subject has any of the following conditions:
- Dermatochalasis with <2mm lid margin when looking straight ahead
- Excessive skin laxity/skin aging
- Asymmetry in the upper face
- History of facial nerve palsy
- Eyebrow or eyelid ptosis
- History of neuromuscular disorder
- Chronic dry eye symptoms
- Allergy or intolerance to local anesthetic agents (e.g., Lidocaine)
- Use of narcotic medications for a chronic pain condition
- Other clinically significant local skin condition (e.g., skin infection) at target treatment site
- Any physical or psychiatric condition that in the Investigator's opinion would prevent treatment or adequate study participation
- Chronic medical condition that in the Investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.)
- Known diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the Investigator
- Fitzpatrick Skin Type V or VI (see Table 3)
- Subject currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of wrinkle treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
DeNova Research
Chicago, Illinois, 60611
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Nashville Center for Laser and Facial Surgery
Nashville, Tennessee, 37203
Laser & Skin Surgery Center of NY
New York, New York, 10016
Roseville Facial Plastic Surgery
Roseville, California, 95661
About this study
Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the appearance of forehead wrinkles.
- Conditions
- Forehead Wrinkles
- Being tested
- iovera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ioveraDevice
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment with iovera | Experimental | Immediate treatment with iovera Receives: Device: iovera |
| Delayed Treatment with iovera | Active comparator | Delayed Treatment with iovera Receives: Device: iovera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on the 5-point Wrinkle Scale
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forehead 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950065
- Sponsor's protocol ID
- MYO-0806
- Status last verified
- Mar 2015
- First submitted
- 17 Sep 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Study of the Iovera Device for the Temporary Reduction in the Appearance of Forehead Wrinkles
- ClinicalTrials.gov ID
- NCT01950065
- Acronym / sponsor ID
- MYO-0806
- Conditions
- Forehead Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Sep 2013 (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.
Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the appearance of forehead wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment with iovera | Experimental | Device: ioveraImmediate treatment with iovera |
| Delayed Treatment with iovera | Active comparator | Device: ioveraDelayed Treatment with iovera |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 65 years
- Subject has a forehead wrinkle rating by the Investigator/designee of at least "2" in full contraction on the 5-point Wrinkle Scale (5WS) as rated by the study Investigator, which, upon physical manipulation/separation of the skin, demonstrates a reduction in wrinkle severity
- Subject has a glabella wrinkle rating by the Investigator/designee of at least "1" in full contraction on the 5-point Glabella Scale (5GS)
- Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5-point Wrinkle Scale (5WS) as rated by the Investigator/designee
- Subject has Fitzpatrick Skin Type I, II, III, or IV (see Error! Reference source not found.)
Key exclusion criteria (24 listed)
- Subject has a clotting disorder or coagulopathy that requires regular use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidogrel, etc.)
- Subject has used aspirin or any non-steroidal anti-inflammatory drugs (NSAIDs) within seven (7) days prior to screening or use of the device
- Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
- Subject has undergone another surgical cosmetic procedure or botulinum toxin injection at or above the level of the zygoma (cheekbones) within the past six (6) months prior to screening
- Subject has a resting wrinkle score of "3" or higher on the 5WS as rated by the study Investigator
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 |
|---|---|---|
| iovera | Device | Delayed Treatment with iovera, Immediate Treatment with iovera |
Primary outcome
Improvement on the 5-point Wrinkle Scale
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Active, not recruitingEarly Phase 1
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A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iovera in people with Forehead Wrinkles, run by Pacira Pharmaceuticals, Inc at 6 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 8 inclusion and 24 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement on the 5-point Wrinkle Scale (time frame: 30 Days). 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 24 Mar 2015.