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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This 3-day study will enroll subjects with mild to moderate atopic dermatitis, as defined by the Hanifin criteria. All subjects will be screened for study enrollment at the baseline visit. Those meeting inclusion/exclusion criteria will be fully consented (or assented) using an IRB-approved ICF. Subjects will then be randomized to either the treatment or control study arm. Those in the treatment arm will be instructed on product application technique and study instructions at baseline. Subjects will apply Aurstat BID, or as needed, to determine frequency of use as a surrogate marker for duration of therapy effect to affected, qualifying atopic dermatitis lesions. The investigator will assess treatment response using an ordinal scale for tolerability and an IGA scale for disease severity ratings. Subjects will assess treatment response using a VAS to rate pruritus and an ordinal scale to assess tolerability. Photography assessments will be obtained. All adverse events will be captured.

Official Title
-----------------
A 3-Day Investigator Blinded, Randomized Study Evaluating Aurstat Anti-Itch Hydrogel Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus

Conditions
-----------------
Pruritus, Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Aurstat Anti-Itch Hydrogel (Aurstat)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Untreated Control Group<br>Subjects will apply nothing for the entire three days of the trial. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. | |
| Active Comparator: Treatment Group (Aurstat)<br>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. | Drug: Aurstat Anti-Itch Hydrogel (Aurstat)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Itching in AD | The ability of Aurstat to reduce itching in those diagnosed with Atopic Dermatitis aged 12-75 years of age. Visual analog score (VAS assessment)- the VAS itch score was defined as the number of millimeters from the left side of a line (154 mm in length) that indicates their level of itching (0 mm (no itching)-154 mm (most itching)). | 3-days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pruritus, Atopic Dermatitis