Status:
COMPLETED
Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Frown Lines
Glabellar Frown Lines
Eligibility:
All Genders
30-65 years
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 devi...
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 subcutane...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01808742
Start Date
November 1 2012
End Date
August 1 2014
Last Update
March 24 2015
Active Locations (1)
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1
77 Plastic Surgery
San Francisco, California, United States, 94102