Laser Treatment for the Improvement of Scars and Scleroderma

Korábbi kezelés

• Participation in another investigational drug or device clinical trial in the past 30 days;
• Use of any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months;
• Regular intake of high doses of anti-inflammatory drugs (aspirin >81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;

Más betegség

• History of allergic reaction to topical or local anesthesia;
• Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Egyéb

• Are pregnant or lactating;

• Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
• In good general health, based on answers provided during the screening visit;
• Subject must be able to read and understand English;
• Any gender and any Fitzpatrick skin type;
• Age equal to or greater than 18 years old;
• Subjects in the hypertrophic scar branch must have at least one extragenital hypertrophic scar (defined as abnormal proliferation of scar tissue that forms at the site of cutaneous injury and does not regress and grows beyond the original margins of the scar) large enough to treat for both the control and experimental arm (at least 4cm in length for spit scar treatment) or two similar hypertrophic scars (at least 4cm2 for each);
• Subjects in the scleroderma branch must have eligible extragenital lesions; large enough to treat for both the control and experimental arm or two similar scleroderma areas (at least 4cm2 area for each);