Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles

NCT01984619 | Completed

• 1 other identifier: MYO-0834
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for the treatment of forehead wrinkles.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (1)

• Wrinkle severity when eyebrows are elevated at 30 days post-treatment.

  120 Days

Other Outcomes (1)

• Anticipated observations, adverse events and SAEs/UADEs will be assessed at each visit.

  120 Days

Study Arms (1)

Blunt Tip Cannula

Device: Cryotherapy for the utilization of wrinkle reduction (iovera)

Interventions

Cryotherapy for the utilization of wrinkle reduction (iovera) DEVICE

Also known as: iovera

Blunt Tip Cannula

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects, male or female, age 18 - 65 with forehead wrinkles deemed significant per protocol inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

The Aesthetics Research Center

Redwood City, California, 94043, United States

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

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

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 15, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (1)