Recruitment

Recruitment Status
Completed
Estimated Enrollment
75

Inclusion Criterias

Fitzpatrick Skin Type I, II, III, or IV.
Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
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.
...
Fitzpatrick Skin Type I, II, III, or IV.
Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
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.
Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5WS.
Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
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.
Male or Females 18-65 years of age.

Exclusion Criterias

Dermatochalasis with <1mm lid margin when looking straight ahead.
Chronic dry eye symptoms.
Open and/or infected wounds
...
Dermatochalasis with <1mm lid margin when looking straight ahead.
Chronic dry eye symptoms.
Open and/or infected wounds
Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.
Raynaud's Disease
Subjects who actively elevate forehead at rest.
History of neuromuscular disorder.
Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
Use of narcotic medication for a chronic pain condition.
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.
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.
Paroxysmal cold hemoglobinuria
Cold Uticaria
Subject is currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of the iovera° treatment.
Subject has a clotting disorder or coagulopathy that requires use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidigrel, etc.)
Eyebrow or eyelid ptosis.
History of facial nerve palsy.
Chronic medical condition that in the Investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).
Any physical or psychiatric condition that in the Investigator's opinion would prevent adequate study participation.
Cryoglobinemia
Asymmetry in the upper face.
Excessive skin laxity.
Allergy or intolerance to local anesthetic agents (e.g., Lidocaine).
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.
Fitzpatrick Skin Type V or IV
Subject has a resting wrinkle score of "3" or higher on the 5WS.
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.
Existing neuromuscular disease

Summary

Conditions
Wrinkles
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criterias

Fitzpatrick Skin Type I, II, III, or IV.
Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
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.
...
Fitzpatrick Skin Type I, II, III, or IV.
Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
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.
Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5WS.
Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
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.
Male or Females 18-65 years of age.

Exclusion Criterias

Dermatochalasis with <1mm lid margin when looking straight ahead.
Chronic dry eye symptoms.
Open and/or infected wounds
...
Dermatochalasis with <1mm lid margin when looking straight ahead.
Chronic dry eye symptoms.
Open and/or infected wounds
Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.
Raynaud's Disease
Subjects who actively elevate forehead at rest.
History of neuromuscular disorder.
Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
Use of narcotic medication for a chronic pain condition.
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.
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.
Paroxysmal cold hemoglobinuria
Cold Uticaria
Subject is currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of the iovera° treatment.
Subject has a clotting disorder or coagulopathy that requires use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidigrel, etc.)
Eyebrow or eyelid ptosis.
History of facial nerve palsy.
Chronic medical condition that in the Investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).
Any physical or psychiatric condition that in the Investigator's opinion would prevent adequate study participation.
Cryoglobinemia
Asymmetry in the upper face.
Excessive skin laxity.
Allergy or intolerance to local anesthetic agents (e.g., Lidocaine).
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.
Fitzpatrick Skin Type V or IV
Subject has a resting wrinkle score of "3" or higher on the 5WS.
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.
Existing neuromuscular disease

Locations

Redwood City, California, 94043
Redwood City, California, 94043

Tracking Information

NCT #
NCT01984619
Collaborators
Not Provided
Investigators
Not Provided