CompletedNot Applicable

Dermal Cryotherapy for Treatment of Pigmented Lesions

United States, Canada377 participantsStarted 2016-06

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Reduction of pigmentation in treated lesions

Timeframe: 90 days

NCT IDNCT02848742

SponsorR2 Dermatology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.