NCT01950065

Brief Summary

Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the appearance of forehead wrinkles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

September 17, 2013

Last Update Submit

March 23, 2015

Conditions

Forehead Wrinkles

Outcome Measures

Primary Outcomes (1)

  • Improvement on the 5-point Wrinkle Scale

    30 Days

Study Arms (2)

Immediate Treatment with iovera

EXPERIMENTAL

Immediate treatment with iovera

Device: iovera

Delayed Treatment with iovera

ACTIVE COMPARATOR

Delayed Treatment with iovera

Device: iovera

Interventions

ioveraDEVICE
Delayed Treatment with ioveraImmediate Treatment with iovera

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years
  • Subject has a forehead wrinkle rating by the Investigator/designee of at least "2" in full contraction on the 5-point Wrinkle Scale (5WS) as rated by the study Investigator, which, upon physical manipulation/separation of the skin, demonstrates a reduction in wrinkle severity
  • Subject has a glabella wrinkle rating by the Investigator/designee of at least "1" in full contraction on the 5-point Glabella Scale (5GS)
  • Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5-point Wrinkle Scale (5WS) as rated by the Investigator/designee
  • Subject has Fitzpatrick Skin Type I, II, III, or IV (see Error! Reference source not found.)
  • Subject understands and commits to comply with study requirements
  • Subject is in good general health and free of any condition that could impair either complete study participation or evaluation of forehead wrinkle rating
  • Subject is willing and able to give written informed consent

You may not qualify if:

  • Subject has a clotting disorder or coagulopathy that requires regular use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidogrel, etc.)
  • Subject has used aspirin or any non-steroidal anti-inflammatory drugs (NSAIDs) within seven (7) days prior to screening or use 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 screening
  • Subject has a resting wrinkle score of "3" or higher on the 5WS as rated by the study Investigator
  • Subject actively elevates forehead during rest
  • Subject has been treated with any fillers listed in Error! Reference source not found. in the temple or forehead area in the time intervals specified prior to screening
  • Subject has any of the following conditions:
  • Dermatochalasis with \<2mm lid margin when looking straight ahead
  • Excessive skin laxity/skin aging
  • Asymmetry in the upper face
  • History of facial nerve palsy
  • Eyebrow or eyelid ptosis
  • History of neuromuscular disorder
  • Chronic dry eye symptoms
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Roseville Facial Plastic Surgery

Roseville, California, 95661, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Laser & Skin Surgery Center of NY

New York, New York, 10016, United States

Location

Nashville Center for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 25, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

US(6)