Evaluation of a New Dermal Cryotherapy System

Completed · Not applicable

Conditions studied: Skin Lightening

In brief

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

Key facts

Study ID

NCT02744794

Run by

R2 Dermatology

People needed

175

Starts

2015-04-27

Expected to finish

2018-06-12

Last updated by the study team

2018-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center of Dermatology and Laser Surgery — Sacramento, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Bowes Dermatology — Miami, Florida, United States

Full record on ClinicalTrials.gov

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