Dermal Cryotherapy for Treatment of Pigmented Lesions

This study is a prospective, non-randomized, multi-center study of the Dermal Cooling System
to verify that the device causes a reduction in pigmentation in benign pigmented lesions, and
to determine at what parameters the device is most effective.

Inclusion Criteria:

1. Male or female subjects > 18 years of age.

2. Subject has one or more benign pigmented lesions (e.g., solar lentigines, melasma,
freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment

3. Subject is willing to have up to 40 treatment sites and/or an area up to 8 square
inches treated depending on the size and nature of the lesions identified.

4. Subject is willing to have digital photographs taken of the treatment area and agrees
to use of photographs for presentation, educational, or marketing purposes.

5. Subject is willing to cover treated area or have very limited sun exposure and use an
approved sunscreen of SPF 50 or higher on the treated areas for the duration of the
study, including the follow-up period, if requested.

6. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Physician prescribed medical or surgical treatment, or use of over-the-counter
products to alter skin color, in the area of intended treatment in the previous 6
months (e.g., hydroquinone, corticosteroids, laser surgery)

2. 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

3. Scars or tattoos in the location of the treatment sites

4. History of vitiligo, eczema, or psoriasis in the area of treatment

5. History of melanoma

6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia,
cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.

7. History of abnormal wound healing or abnormal scarring

8. Inability or unwillingness to comply with the study requirements.

9. Current enrollment in a clinical study of any other unapproved investigational drug or
device.

10. 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.