Frown LinesNCT01801826
A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the Cryo-Touch IV Device
An observational study of Frown Lines and Glabellar Frown Lines, run by Pacira Pharmaceuticals, Inc at 2 sites in United States.
Trial summary
myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity resulting in a… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Frown Lines, Glabellar Frown Lines
- What is being tested?
- Treatment with CryoTouch IV
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Dec 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects, male or female, age 30 - 65 with forehead and/or glabellar lines deemed significant per protocol inclusion criteria.
Who may be able to join
- 1. Male or Females 30-65 years of age. 2. 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.
- 3. Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
- 4. Fitzpatrick Skin Type I, II, III, or IV. 5. Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
- 6. 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
- 1. Dermatochalasis with <1mm lid margin when looking straight ahead. 2. Excessive skin laxity. 3. Asymmetry in the upper face. 4. Subjects who actively elevate during a rest cycle. 5. History of facial nerve palsy. 6. Eyebrow or eyelid ptosis. 7. History of neuromuscular disorder. 8. Chronic dry eye symptoms. 9. Allergy or intolerance to lidocaine. 10. 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.
- 11. Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
- 12. Chronic medical condition that in the investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).
- 13. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
- 14. Subject has used aspirin or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen and naproxen) within seven (7) days prior to administration of the device.
- 15. Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
Show all 10Show fewer
- 16. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator.
- 17. 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.
- 18. Subject has been treated with fillers (see Section 2.8 Table 1) in the temple or forehead area in the time intervals specified prior to the start of their participation in the study.
- 19. Subject has a resting wrinkle score of "2" or higher on the 5WS.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beverly Hills International Center for Aesthetic Surgery
Beverly Hills, California, 90211
77 Plastic Surgery
San Francisco, California, 943102
About this study
Official title: A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines Utilizing Optimized Algorithms With the Cryo-Touch IV Device
myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity resulting in a reversible reduction in facial animation and the appearance of facial lines. The device operates on well-established cryobiology principles; that localized exposure to controlled low temperature conditions can alter tissue function. The therapy treats targeted motor nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety for applications in this indication. The goal of the study described herein is to show the safety and effectiveness of this approach using the Cryo-Touch IV device.
Read the detailed description
The development of facial rhytids or wrinkles is a natural part of the aging process, resulting from the thinning of the dermis and epidermis due to a loss of elastic fibers and collagen and subcutaneous fat loss. Contributors to the formation of facial rhytids include exposure to ultraviolet light (sunlight) and gravity, as well as habitual facial expressions which cause lines to occur in specific facial regions as the skin loses elasticity. In some cases, hyperdynamic activity of underlying facial muscles leads to the development of furrows in the glabella and frontalis areas. Activity of the facial muscles causes hyperdynamic lines independent of the aging process and this can also be undesirable.
With an aging population, the demand for facial rejuvenation techniques has increased. A range of treatment options have been developed to provide reduction in facial lines, including topical medications, neuromuscular inhibiting injections, laser treatments, cosmetic fillers, and surgical facelifts. Those options targeted specifically at hyperdynamic furrows include botulinum toxin injection, injectable fillers, and surgical resection of facial muscles or division of motor nerves. Although botulinum toxin injections have become a popular approach to reduction of glabellar lines by providing partial chemical denervation of the glabellar muscle complex, safety concerns exist related to the use of this toxin. Injectable fillers do not mitigate the underlying muscular activity which produces the facial furrows. Surgical strategies are limited by the risks and complications typically associated with surgery, including bleeding, bruising, scarring, and infection. A non-surgical, minimally invasive approach to elimination of facial hyperdynamic lines which avoids the use of chemical toxins is desirable.
myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity resulting in a reversible reduction in facial animation and the appearance of facial lines. The device operates on well-established cryobiology principles; that localized exposure to controlled low temperature conditions can alter tissue function. The therapy treats targeted motor nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety for applications in this indication. The goal of the study described herein is to show the safety and effectiveness of this approach using the Cryo-Touch IV device.
- Conditions
- Frown Lines, Glabellar Frown Lines
- Being tested
- Treatment with CryoTouch IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with CryoTouch IVDevice
Bilateral forehead treatment with the Cryo-Touch IV device on the temporal branch of the facial nerve. Subject will be treated once and may have a retreatment up to 7 days after the first treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Treatment with CryoTouch IV device Receives: Device: Treatment with CryoTouch IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale.
Measured: 30 days
Secondary outcomes (1)
Improvement ratings
Changes in from baseline assessments of wrinkle severity based on ratings by the investigator and subject.
Measured: 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frown LinesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry K Fan, MD, Principal investigator, 77 Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801826
- Sponsor's protocol ID
- MYO-0726
- Status last verified
- Mar 2013
- First submitted
- 26 Feb 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- 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 Forehead and/or Glabellar Lines Utilizing Optimized Algorithms With the Cryo-Touch IV Device
- ClinicalTrials.gov ID
- NCT01801826
- Acronym / sponsor ID
- MYO-0726
- Conditions
- Frown Lines, Glabellar Frown Lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Mar 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.
myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity resulting in a reversible reduction in facial animation and the appearance of facial lines. The device operates on well-established cryobiology principles; that localized exposure to controlled low temperature conditions can alter tissue function. The therapy treats targeted motor nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety for applications in this indication. The goal of the study described herein is to show the safety and effectiveness of this approach using the Cryo-Touch IV device.
Detailed description
The development of facial rhytids or wrinkles is a natural part of the aging process, resulting from the thinning of the dermis and epidermis due to a loss of elastic fibers and collagen and subcutaneous fat loss. Contributors to the formation of facial rhytids include exposure to ultraviolet light (sunlight) and gravity, as well as habitual facial expressions which cause lines to occur in specific facial regions as the skin loses elasticity. In some cases, hyperdynamic activity of underlying facial muscles leads to the development of furrows in the glabella and frontalis areas. Activity of the facial muscles causes hyperdynamic lines independent of the aging process and this can also be undesirable.
With an aging population, the demand for facial rejuvenation techniques has increased. A range of treatment options have been developed to provide reduction in facial lines, including topical medications, neuromuscular inhibiting injections, laser treatments, cosmetic fillers, and surgical facelifts. Those options targeted specifically at hyperdynamic furrows include botulinum toxin injection, injectable fillers, and surgical resection of facial muscles or division of motor nerves. Although botulinum toxin injections have become a popular approach to reduction of glabellar lines by providing partial chemical denervation of the glabellar muscle complex, safety concerns exist related to the use of this toxin. Injectable fillers do not mitigate the underlying muscular activity which produces the facial furrows. Surgical strategies are limited by the risks and complications typically associated with surgery, including bleeding, bruising, scarring, and infection. A non-surgical, minimally invasive approach to elimination of facial hyperdynamic lines which avoids the use of chemical toxins is desirable.
myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity resulting in a reversible reduction in facial animation and the appearance of facial lines. The device operates on well-established cryobiology principles; that localized exposure to controlled low temperature conditions can alter tissue function. The therapy treats targeted motor nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety for applications in this indication. The goal of the study described herein is to show the safety and effectiveness of this approach using the Cryo-Touch IV device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Treatment with CryoTouch IVTreatment with CryoTouch IV device |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects, male or female, age 30 - 65 with forehead and/or glabellar lines deemed significant per protocol inclusion criteria.
Key inclusion criteria (4 listed)
- 1. Male or Females 30-65 years of age. 2. 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.
- 3. Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
- 4. Fitzpatrick Skin Type I, II, III, or IV. 5. Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
- 6. 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.
Key exclusion criteria (10 listed)
- 1. Dermatochalasis with <1mm lid margin when looking straight ahead. 2. Excessive skin laxity. 3. Asymmetry in the upper face. 4. Subjects who actively elevate during a rest cycle. 5. History of facial nerve palsy. 6. Eyebrow or eyelid ptosis. 7. History of neuromuscular disorder. 8. Chronic dry eye symptoms. 9. Allergy or intolerance to lidocaine. 10. 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.
- 11. Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
- 12. Chronic medical condition that in the investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).
- 13. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
- 14. Subject has used aspirin or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen and naproxen) within seven (7) days prior to administration of the device.
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 |
|---|---|---|
| Treatment with CryoTouch IVBilateral forehead treatment with the Cryo-Touch IV device on the temporal branch of the facial nerve. Subject will be treated once and may have a retreatment up to 7 days after the first treatment | Device | Treatment |
Primary outcome
Effectiveness
Time frame: 30 days
Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale.
1 secondary outcome
Improvement ratings
Time frame: 30
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.
Larry K Fan, MD principal investigator
77 Plastic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frown Lines and Glabellar Frown Lines, run by Pacira Pharmaceuticals, Inc at 2 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 4 inclusion and 10 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 2 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?
Effectiveness (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.