NCT01808742

Completed

Study Evaluating the Treatment of Forehead and/or Glabellar ...

Pacira Pharmaceuticals, Inc Source

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Other study identifiers

Sponsor study identifier

MYO-0602

Study Type

observational

Actual enrollment (reported)

17

Locations

1 country

Sites

1

Timeline

Study Start

November 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

Brief 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 III 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 investigate optimized algorithms and ongoing safety and effectiveness.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 17 participants
Study completion date: August 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 7, 2013
Actual (reported)
First Posted
March 11, 2013
Actual (reported)
Primary Completion
July 2014
Actual (reported)
Study Completion
August 2014
Actual (reported)

Last Updated: March 24, 2015
Status Verified: March 2015
Last Update Submitted: March 23, 2015

Conditions

Frown Lines Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

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.
30 days

Secondary Outcomes (1)

improvement rating
56 days

Study Arms (1)

Treatment

Treatment with CryoTouch III device

Device: Treatment with CryoTouch III Device

Interventions

Treatment with CryoTouch III DeviceDevice

Bilateral forehead treatment with CryoTouch III device on the temporal branch of the facial nerve. Subject will be treated once and may be retreated up to 7 days after initial treatment.

Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Healthy subjects, male or female, age 30 - 65 with forehead and/or glabellar lines deemed significant per protocol inclusion criteria.

You may qualify if:

\. 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.

Sponsors & Collaborators

Pacira Pharmaceuticals, Inc
Industrylead

Study Sites (1)

77 Plastic Surgery

San Francisco, California, 94102, United States

MeSH Terms

Interventions

Therapeutics

Study Officials

Larry Fan, MD
77 Plastic Surgery
PRINCIPAL INVESTIGATOR

Enrollment

17 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 11, 2013

Study Start

November 2012

Date type not reported

This date has not been verified as actual or estimated.

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Phase 2Completed

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Phase 2Completed

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Phase 3Completed

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Phase 3Completed

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Phase 2Completed

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\. Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).

\. 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.

\. 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.

You may not qualify if:

\. 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.
\. 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 cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
\. 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.
\. Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
\. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator.
\. 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 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.
\. Subject has a resting wrinkle score of "2" or higher on the 5WS.

Contact the study team to confirm eligibility.

Primary Completion

July 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

Last Updated

March 24, 2015

Record last verified: 2015-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01808742
Data provider: ClinicalTrials.gov
Source updated: 2015-03-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:40 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations