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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate the ability of Aurstat to reduce pruritus in subjects with mild to moderate atopic dermatitis. Efficacy results will be based on subject assessment, IGA, and photographic evidence based on ordinal scales for tolerability.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Center for Clinical and Cosmetic Research
• Collaborator: Onset Dermatologics, Inc.
• Treatments: Diphenhydramine; Promethazine

Criteria

Inclusion Criteria:

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

1. Subjects must be diagnosed by the investigator as meeting the criteria for mild to moderate atopic dermatitis, as defined by the Hanifin criteria.

2. Subjects must score a minimum of 2 on the itch severity scale.

3. 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.

4. No other oral or topical treatments for atopic dermatitis are allowed during the study.

5. Subjects on asthma or allergy medications must continue taking these prescription or OTC products without change during the study.

6. Anti-inflammatory oral medications or oral antihistamines not used at cannot be added during the study or taken on an intermittent basis.

7. 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.

8. 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.

1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's response to the study formulation.

2. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.

3. 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.

4. Subjects who have used a topical corticosteroid within 2 weeks of study enrollment.

5. 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.

6. Subjects who use an indoor tanning booth.

7. Subjects who are pregnant, breast feeding or planning a pregnancy.

8. Subjects with clinically significant unstable medical disorders.