WrinklesNCT01984619
Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles
An observational study of Wrinkles, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for the treatment 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
- Wrinkles
- What is being tested?
- Cryotherapy for the utilization of wrinkle reduction (iovera)
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2014
- Phase
- Observational
- 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
Study population: Healthy subjects, male or female, age 18 - 65 with forehead wrinkles deemed significant per protocol inclusion criteria.
Who may be able to join
- Male or Females 18-65 years of age.
- Forehead wrinkle(s) rating of at least 2 in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation of the skin demonstrates a reduction in wrinkle severity.
- Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5WS.
- Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
- Fitzpatrick Skin Type I, II, III, or IV.
- Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
- Subject is in good general health, free of any disease state, or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the Investigator's opinion, exposes the subject to an unacceptable risk by study participation.
Who cannot join
- Subject has a clotting disorder or coagulopathy that requires use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidigrel, etc.)
- Subject has used medication or supplements affecting clotting cascade (e.g., aspirin, fish oil, etc.), or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen and naproxen) within seven (7) days prior to administration 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 administration of the device.
- Subject has a resting wrinkle score of "3" or higher on the 5WS.
- Subjects who actively elevate forehead at rest.
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- Subject has been treated with fillers in the temple or forehead area in the time intervals specified prior to the start of their participation in the study.
- Subject has any of the following:
- Dermatochalasis with <1mm lid margin when looking straight ahead.
- Excessive skin laxity.
- 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 medication for a chronic pain condition.
- Any other clinically significant, in the opinion of the Investigator, local skin condition (e.g., skin infection) at target treatment site that may interfere or be a safety concern.
- Any physical or psychiatric condition that in the Investigator's opinion would prevent adequate study participation.
- Chronic medical condition that in the Investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).
- Diagnosis of:
- Cryoglobinemia
- Paroxysmal cold hemoglobinuria
- Cold Uticaria
- Raynaud's Disease
- Open and/or infected wounds
- Existing neuromuscular disease
- Fitzpatrick Skin Type V or IV
- Subject is currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of the iovera° treatment.
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Aesthetics Research Center
Redwood City, California, 94043
About this study
Official title: A Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles Utilizing the Iovera With Blunt Tip Cannula Smart Tip
To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for the treatment of forehead wrinkles.
- Conditions
- Wrinkles
- Being tested
- Cryotherapy for the utilization of wrinkle reduction (iovera)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy for the utilization of wrinkle reduction (iovera)Device
Also called iovera
| Study group | Role | What they receive |
|---|---|---|
| Blunt Tip Cannula | Not described Receives: Device: Cryotherapy for the utilization of wrinkle reduction (iovera) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle severity when eyebrows are elevated at 30 days post-treatment.
Measured: 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 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
- NCT01984619
- Sponsor's protocol ID
- MYO-0834
- Status last verified
- Mar 2015
- First submitted
- 29 Oct 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
- A Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles Utilizing the Iovera With Blunt Tip Cannula Smart Tip
- ClinicalTrials.gov ID
- NCT01984619
- Acronym / sponsor ID
- MYO-0834
- Conditions
- Wrinkles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Nov 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.
To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for the treatment of forehead wrinkles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blunt Tip Cannula | – | Device: Cryotherapy for the utilization of wrinkle reduction (iovera) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects, male or female, age 18 - 65 with forehead wrinkles deemed significant per protocol inclusion criteria.
Key inclusion criteria (7 listed)
- Male or Females 18-65 years of age.
- Forehead wrinkle(s) rating of at least 2 in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation of the skin demonstrates a reduction in wrinkle severity.
- Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5WS.
- Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
- Fitzpatrick Skin Type I, II, III, or IV.
Key exclusion criteria (30 listed)
- Subject has a clotting disorder or coagulopathy that requires use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidigrel, etc.)
- Subject has used medication or supplements affecting clotting cascade (e.g., aspirin, fish oil, etc.), or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen and naproxen) within seven (7) days prior to administration 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 administration of the device.
- Subject has a resting wrinkle score of "3" or higher on the 5WS.
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 |
|---|---|---|
| Cryotherapy for the utilization of wrinkle reduction (iovera)Also: iovera | Device | Blunt Tip Cannula |
Primary outcome
Wrinkle severity when eyebrows are elevated at 30 days post-treatment.
Time frame: 120 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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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkles, run by Pacira Pharmaceuticals, Inc at 1 site 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 7 inclusion and 30 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 1 site 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?
Wrinkle severity when eyebrows are elevated at 30 days post-treatment. (time frame: 120 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.