Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus

Inclusion Criteria

Patients who meet all of the following criteria are eligible for this study.

• Subjects must be diagnosed by the investigator as meeting the criteria for mild to moderate atopic dermatitis, as defined by the Hanifin criteria.
• Subjects must score a minimum of 2 on the itch severity scale.
• Subjects may not apply other topical products (including moisturizers) to the affected lesions, other than study treatments, for a minimum of 24 hours prior to study initiation and for the duration of the study.
• No other oral or topical treatments for atopic dermatitis are allowed during the study.
• Subjects on asthma or allergy medications must continue taking these prescription or OTC products without change during the study.
• Anti-inflammatory oral medications or oral antihistamines not used at cannot be added during the study or taken on an intermittent basis.
• Subjects must be 12-75 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation, except mild to moderate atopic dermatitis.
• Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide), and abstinence.

Exclusion Criteria

Patients who meet any of the following criteria are not eligible for this study.

• Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's response to the study formulation.
• Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.
• Concurrent therapy with any medication either topical or oral that might interfere with the investigator and/or subject assessments of atopic dermatitis or study product irritancy, based on the opinion of the investigator.
• Subjects who have used a topical corticosteroid within 2 weeks of study enrollment.
• Subjects who are on oral corticosteroids within 4 weeks of study enrollment, inhaled corticosteroids are allowed if used at baseline and used on a routine basis. Intermittent inhaled corticosteroids are prohibited.
• Subjects who use an indoor tanning booth.
• Subjects who are pregnant, breast feeding or planning a pregnancy.
• Subjects with clinically significant unstable medical disorders.