Evaluation of a New Dermal Cryotherapy System

Study Overview
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Brief Summary
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A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.

Detailed Description
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This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.

Official Title
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Evaluation of a New Dermal Cryotherapy System

Conditions
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Skin Lightening

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. Subject is willing to have up to 40 test sites treated on aesthetically discreet skin. 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: Fitzpatrick skin type VI. Physician prescribed, medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery) 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 Dermatological conditions or scars in the location of the treatment sites History of melanoma, personal or first degree relative Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease. History of abnormal wound healing or abnormal scarring Inability or unwillingness to comply with study requirments. Current enrollment in a clinical study of any other unapproved investigational drug or device. 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 subject.

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 cryotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin pigmentation changes | Changes in pigmentation graded using a 7-point standardized scale | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of device- or procedure-related adverse events | Side effects, discomfort assessments both during treatment and follow-up. | 0 to 12 months |