Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
Condition: Pruritus; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Intervention: Aurstat Anti-Itch Hydrogel (Aurstat)
Intervention description: Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.
Intervention MeSH terms: Diphenhydramine; Promethazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pruritus; Atopic Dermatitis

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.
    

Eligibility 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.