Dermal Cryotherapy in Patients Undergoing Abdominoplasty

Study Overview
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Brief Summary
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A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.

Detailed Description
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This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.

Official Title
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Dermal Cryotherapy in Patients Undergoing Abdominoplasty

Conditions
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Skin Laxity

Intervention / Treatment
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* Device: Dermal Cooling System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects > 18 years of age. Subjects eligible, consented, and scheduled for abdominoplasty. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period. Subject has read and signed a written informed consent form. - Exclusion Criteria: Subject has medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., liposuction, mesotherapy, hydroquinone, corticosteroids, laser surgery). Subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, Enbrel). Subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease). Subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline) Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period. Subject is unable or unwilling to comply with the study requirements. Subject has any dermatological conditions or scars (other than stretch marks) within the area of planned abdominoplasty excision that may interfere with the ability to obtain test sites for treatment or evaluation. Subject has a history of abnormal wound healing or abnormal scarring. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. Patient is pregnant or intending to become pregnant within the next 6 months. Patient is lactating or has been lactating in the past 9 months. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with cryotherapy<br>Treatment with dermal cooling system. | Device: Dermal Cooling System<br>* Treatment with dermal cooling system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic evaluation of treated skin | Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments. | 1-180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access device or procedure-related adverse events | Assess adverse events and side effects. | 1 - 180 days |