Phase
Condition
Skin Cancer
Pressure Ulcer
Treatment
Dermal Cooling System
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects > 18 years of age.
Subject has a skin condition amenable to cryosurgical treatment including, forexample, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
Subject is willing to have digital photographs taken of the treatment area andagrees to use of photographs for presentation, educational, or marketing purposes.
Subject is willing to cover treated area or have very limited sun exposure and usean approved sunscreen of SPF 50 or higher on the treated area for the duration ofthe study, including the follow-up period, if requested.
Subject has read and signed a written informed consent form.
Subject is willing to comply with adjuvant topical regimen, as applicable.
Subject agrees not to undergo any other procedure(s) in the treatment area duringthe study.
Exclusion
Exclusion Criteria:
Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous ormalignant lesions) in the location of the treatment sites that would, in theprofessional opinion of the investigator, potentially pose an increased risk to thesubject
Use of Accutane within the previous 6 months
History of melanoma
Subject is pregnant or intending to become pregnant during the study period
Subject is lactating or has been lactating in the past 6 months
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 the study requirements.
Current enrollment in a clinical study of any other unapproved investigational drugor device.
Any other condition or laboratory value that would, in the professional opinion ofthe investigator, potentially affect response or participation in this clinicalstudy, or would pose an unacceptable risk to the subject.
Study Design
Study Description
Connect with a study center
West Coast Research
Dublin, California 94568
United StatesSite Not Available
Oak Dermatology
Naperville, Illinois 60563
United StatesSite Not Available
Skin Search of Rochester, Inc.
Rochester, New York 14623
United StatesSite Not Available
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina 28207
United StatesSite Not Available
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