Dermal Cryotherapy for Treatment of Pigmented Lesions

Completed · Not applicable

Conditions studied: Pigmented Skin Lesion

In brief

Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions.

Key facts

Study ID

NCT02848742

Run by

R2 Dermatology

People needed

377

Starts

2016-06-01

Expected to finish

2020-03-01

Last updated by the study team

2021-03-29

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 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
• 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.
• Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
• 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.
• Subject has read and signed a written informed consent form.

You may not qualify if…

• 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)
• 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
• Scars or tattoos in the location of the treatment sites
• History of vitiligo, eczema, or psoriasis in the area of treatment
• History of melanoma
• 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 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

• Diablo Clinical Research — Walnut Creek, California, United States
• Arbutus Laser Centre — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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